Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Intergroupe Francophone du Myelome
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00430365
First received: January 31, 2007
Last updated: November 8, 2013
Last verified: November 2013

January 31, 2007
November 8, 2013
June 2006
February 2015   (final data collection date for primary outcome measure)
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
Complete list of historical versions of study NCT00430365 on ClinicalTrials.gov Archive Site
  • Assess the impact of Revlimid® on the post-transplant complete response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Compare survival without events and overall survival of patients in the lenalidomide arm with the control [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Assess the impact of Revlimid® on the post-transplant complete response rate
  • Compare survival without events and overall survival of patients in the Revlimid® arm with the control
  • Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
Not Provided
Not Provided
 
Maintenance Therapy Using Lenalidomide in Myeloma
Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).

Maintenance treatment of myeloma.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myeloma
  • Drug: lenalidomide
    oral drug
    Other Name: REVLIMID
  • Drug: placebo
    oral placebo
  • Placebo Comparator: 2
    Administration of oral placebo
    Intervention: Drug: placebo
  • Experimental: 1
    Administration of lenalidomide
    Intervention: Drug: lenalidomide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
614
June 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No signs of progression after transplant
  • Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males)
  • No active severe infection
  • Satisfactory restoration of the haematological parameters defined by: PN >1,000/mm3 and Platelets > 75,000/mm3
  • Bilirubin < 35 umol/l and GOT/GPT/PAL<3N
  • Creatinine < 160 umol/l.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Switzerland
 
NCT00430365
0400401, French PHRC
Yes
University Hospital, Toulouse
University Hospital, Toulouse
  • Intergroupe Francophone du Myelome
  • Celgene Corporation
Principal Investigator: ATTAL Michel, Pr University Hospital, Toulouse
University Hospital, Toulouse
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP