A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00420849

First received: January 9, 2007

Last updated: May 15, 2012

Last verified: May 2012

History of Changes

Results First Received: February 10, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Myeloma
Interventions:	Drug: Lenalidomide Drug: Dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Participant Flow: Overall Study

	Lenalidomide Plus Dexamethasone
STARTED	587
COMPLETED	256 ^[1]
NOT COMPLETED	331
Lack of Efficacy	154
Adverse Event	107
Withdrawal by Subject	28
Death	18
Not specified	14
Transplant	8
Protocol Violation	1
Lost to Follow-up	1

[1]	Participants completed the study upon commercial availability of lenalidomide

Baseline Characteristics

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Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Baseline Measures

	Lenalidomide Plus Dexamethasone
Number of Participants [units: participants]	587
Age [units: years] Mean ± Standard Deviation	64.5 ± 9.74
Age, Customized [units: participants]
<=18 years	0
>18 and <=65 years	314
>65 years	273
Gender [units: participants]
Female	241
Male	346
Race/Ethnicity, Customized [units: participant]
White	548
Other	17
Asian / Pacific Islander	10
Black	9
Hispanic	3

Outcome Measures

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1. Primary:

Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 123 weeks ]

Measure Type	Primary
Measure Title	Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment
Measure Description	Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.
Time Frame	up to 123 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Measured Values

	Lenalidomide Plus Dexamethasone
Number of Participants Analyzed [units: participants]	587
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment [units: participants]
At least one treatment-emergent AE (TEAE)	586
At least one TEAE related to study drug	519
At least one TEAE with severity grade of 3 or 4	471
At least one serious AE (SAE)	340

No statistical analysis provided for Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment

2. Secondary:

Participants With Adverse Events of Special Interest: Peripheral Neuropathy [ Time Frame: up to 124 weeks ]

Measure Type	Secondary
Measure Title	Participants With Adverse Events of Special Interest: Peripheral Neuropathy
Measure Description	Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.
Time Frame	up to 124 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Measured Values

	Lenalidomide Plus Dexamethasone
Number of Participants Analyzed [units: participants]	587
Participants With Adverse Events of Special Interest: Peripheral Neuropathy [units: participants]
At least one TEAE of peripheral neuropathy	84
Neuropathy peripheral	46
Peripheral sensory neuropathy	33
Neuralgia	5
Peripheral motor neuropathy	2
Polyneuropathy	2
Sensory disturbance	1

No statistical analysis provided for Participants With Adverse Events of Special Interest: Peripheral Neuropathy

3. Secondary:

Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE) [ Time Frame: up to 124 weeks ]

Measure Type	Secondary
Measure Title	Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)
Measure Description	Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.
Time Frame	up to 124 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Measured Values

	Lenalidomide Plus Dexamethasone
Number of Participants Analyzed [units: participants]	587
Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE) [units: weeks] Mean ± Standard Deviation	25.6 ± 21.53

No statistical analysis provided for Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)

4. Secondary:

Participants With Adverse Events of Special Interest: Venous Thromboembolic Events [ Time Frame: up to 124 weeks ]

Measure Type	Secondary
Measure Title	Participants With Adverse Events of Special Interest: Venous Thromboembolic Events
Measure Description	Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.
Time Frame	up to 124 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Measured Values

	Lenalidomide Plus Dexamethasone
Number of Participants Analyzed [units: participants]	587
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events [units: participants]
At least one venous thromboembolic event	60
Deep vein thrombosis	38
Pulmonary embolism	23
Thrombophlebitis	7
Venous thrombosis limb	1

No statistical analysis provided for Participants With Adverse Events of Special Interest: Venous Thromboembolic Events

5. Secondary:

Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE) [ Time Frame: up to 124 weeks ]

Measure Type	Secondary
Measure Title	Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)
Measure Description	Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.
Time Frame	up to 124 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups

	Description
Lenalidomide Plus Dexamethasone	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Measured Values

	Lenalidomide Plus Dexamethasone
Number of Participants Analyzed [units: participants]	587
Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE) [units: weeks] Mean ± Standard Deviation	26.5 ± 21.51

No statistical analysis provided for Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)

6. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	153	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale [units: units on a scale] Mean ± Standard Deviation	-3.6 ± 16.19	-2.9 ± 16.54	-1.8 ± 15.10

No statistical analysis provided for Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale

7. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	122	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale [units: units on a scale] Mean ± Standard Deviation	-2.4 ± 26.05	-1.5 ± 32.50	-2.6 ± 31.61

8. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	151	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale [units: units on a scale] Mean ± Standard Deviation	-0.2 ± 15.92	-4.0 ± 19.17	-0.7 ± 27.32

9. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale [units: units on a scale] Mean ± Standard Deviation	-1.9 ± 19.61	-4.9 ± 23.06	3.5 ± 16.96

10. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale [units: units on a scale] Mean ± Standard Deviation	-5.2 ± 26.25	-5.3 ± 29.67	-3.1 ± 30.72

11. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale [units: units on a scale] Mean ± Standard Deviation	2.6 ± 20.93	5.3 ± 26.59	1.0 ± 22.07

12. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	153	125	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale [units: units on a scale] Mean ± Standard Deviation	-3.9 ± 25.56	-5.2 ± 28.35	-6.6 ± 32.77

13. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale [units: units on a scale] Mean ± Standard Deviation	1.0 ± 13.99	0.1 ± 17.14	-2.2 ± 19.82

14. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	150	123	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale [units: units on a scale] Mean ± Standard Deviation	1.1 ± 31.71	7.9 ± 26.68	2.6 ± 37.47

15. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	151	123	37
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale [units: units on a scale] Mean ± Standard Deviation	8.6 ± 24.18	8.1 ± 24.27	9.0 ± 24.40

16. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	151	123	37
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale [units: units on a scale] Mean ± Standard Deviation	-3.8 ± 29.70	2.2 ± 35.38	-1.8 ± 34.20

17. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	148	122	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale [units: units on a scale] Mean ± Standard Deviation	2.7 ± 25.94	2.7 ± 27.97	-0.9 ± 28.46

18. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	123	37
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale [units: units on a scale] Mean ± Standard Deviation	0.4 ± 27.12	3.3 ± 30.60	-4.5 ± 29.57

19. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale
Measure Description	EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	121	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale [units: units on a scale] Mean ± Standard Deviation	2.0 ± 20.74	0.8 ± 22.14	0.9 ± 16.42

20. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
Measure Description	EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	152	122	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale [units: units on a scale] Mean ± Standard Deviation	1.1 ± 20.90	-1.8 ± 23.17	-2.2 ± 21.81

21. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Measure Description	EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	151	122	37
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale [units: units on a scale] Mean ± Standard Deviation	-2.4 ± 16.79	-1.2 ± 17.62	-3.9 ± 19.00

22. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale
Measure Description	EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	151	121	37
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale [units: units on a scale] Mean ± Standard Deviation	4.9 ± 13.22	4.7 ± 13.16	2.0 ± 13.45

23. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Measure Description	EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	150	119	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale [units: units on a scale] Mean ± Standard Deviation	5.8 ± 21.14	3.4 ± 21.70	4.4 ± 21.85

24. Secondary:

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale [ Time Frame: Baseline (Day 0), Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
Measure Description	EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.
Time Frame	Baseline (Day 0), Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set of participants who completed the questionnaire at baseline and week 24.

Reporting Groups

	Description
Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain	Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.

Measured Values

	Lenalidomide - Subpopulation From Austria + Australia	Lenalidomide - Subpopulation From UK + Ireland	Lenalidomide - Subpopulation From Spain
Number of Participants Analyzed [units: participants]	149	117	38
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale [units: units on a scale] Mean ± Standard Deviation	-4.3 ± 35.15	-2.0 ± 33.42	-5.3 ± 31.51

Serious Adverse Events

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Other Adverse Events

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 1 year after study completion. Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 180 days.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was defined primarily as an expanded access program in the selected countries. Treatment was to continue until disease progression, study drug was discontinued for any reason, or lenalidomide became commercially available for indication.

Results Point of Contact:

Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided by Celgene Corporation

Publications automatically indexed to this study:

Alegre A, Oriol-Rocafiguera A, Garcia-Larana J, Mateos MV, Sureda A, Martinez-Chamorro C, Cibeira MT, Aguado B, Knight R, Rosettani B. Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. Leuk Lymphoma. 2012 Sep;53(9):1714-21. Epub 2012 Mar 1.

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00420849 History of Changes
Other Study ID Numbers:	CC-5013-MM-018, 2006-002517-12
Study First Received:	January 9, 2007
Results First Received:	February 10, 2012
Last Updated:	May 15, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Ireland: Irish Medicines Board Spain: Agencia Española de Medicamentos y Productos Sanitarios Austria: Austrian Medicines and Medical Devices Agency

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