A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma

This study has been completed.

Sponsor:

Information provided by:

Gruppo Italiano Studio Linfomi

ClinicalTrials.gov Identifier:

NCT01274403

First received: December 28, 2010

Last updated: January 10, 2011

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 28, 2010
Last Updated Date	January 10, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: January 10, 2011)	To assess the efficacy [ Time Frame: from 8 to 12 months ] [ Designated as safety issue: No ] To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment To assess the toxicity [ Time Frame: From 1 to 12 months ] [ Designated as safety issue: Yes ] To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01274403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 10, 2011)	To evaluate the Overall Survival (OS) in the 2 arms of treatment [ Time Frame: From 1 to 60 months ] [ Designated as safety issue: No ] OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause To evaluate the Duration of Remission (DR) in the 2 arms of treatment [ Time Frame: From 8 to 60 months ] [ Designated as safety issue: No ] DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
Official Title ^ICMJE	Not Provided
Brief Summary	The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: Melphalan, Prednisone and Thalidomide
Study Arm (s)	Experimental: Melphalan, prednisone plus Thalidomide Intervention: Drug: Melphalan, Prednisone and Thalidomide Active Comparator: Melphalan and Prednisone Intervention: Drug: Melphalan, Prednisone and Thalidomide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	130
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: newly diagnosed of multiple myeloma. Age > 65 years ECOG <= 3 Written informed consent given at the time of randomization Patients with age <= 65 but not eligible for high dose treatment with stem cells support Exclusion Criteria: ECOG > 3 current neoplasm.. contraindications to use thalidomide peripheral neurophaty
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01274403
Other Study ID Numbers ^ICMJE	MM03
Has Data Monitoring Committee	No
Responsible Party	Gruppo Italiano Studio Linfoma, GISL
Study Sponsor ^ICMJE	Gruppo Italiano Studio Linfomi
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gruppo Italiano Studio Linfomi
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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