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
  Purpose

Maintenance treatment of myeloma.


Condition Intervention Phase
Myeloma
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: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Administration of oral placebo
Drug: placebo
oral placebo
Experimental: 1
Administration of lenalidomide
Drug: lenalidomide
oral drug
Other Name: REVLIMID

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430365

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00430365     History of Changes
Other Study ID Numbers: 0400401, French PHRC
Study First Received: January 31, 2007
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014