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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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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 ]

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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 ]

Show Outcome Measure 7

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 ]

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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

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) Emotional Functioning Scale

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 ]

Show Outcome Measure 9

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 ]

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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 ]

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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 ]

Show Outcome Measure 12

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 ]

Show Outcome Measure 13

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 ]

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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 ]

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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 ]

Show Outcome Measure 16

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 ]

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

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 ]

Show Outcome Measure 19

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 ]

Show Outcome Measure 20

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 ]

Show Outcome Measure 21

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 ]

Show Outcome Measure 22

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 ]

Show Outcome Measure 23

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 ]

Show Outcome Measure 24

Serious Adverse Events

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Other Adverse Events

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More Information

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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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