Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

This study is ongoing, but not recruiting participants.
Intergroupe Francophone du Myelome
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: January 31, 2007
Last updated: August 18, 2015
Last verified: August 2015
Maintenance treatment of myeloma.

Condition Intervention Phase
Drug: lenalidomide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 614
Study Start Date: June 2006
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo group
Administration of oral placebo
Drug: placebo
oral placebo
Experimental: lenalidomide group
Administration of lenalidomide
Drug: lenalidomide
oral drug
Other Name: REVLIMID


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00430365

  Show 77 Study Locations
Sponsors and Collaborators
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Celgene Corporation
Principal Investigator: ATTAL Michel, Pr University Hospital, Toulouse
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse Identifier: NCT00430365     History of Changes
Other Study ID Numbers: 0400401, French PHRC
Study First Received: January 31, 2007
Last Updated: August 18, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Maintenance therapy
Autologous Stem Cell Transplantation

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015