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Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00430365
Recruitment Status : Active, not recruiting
First Posted : February 1, 2007
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Maintenance treatment of myeloma.

Condition or disease Intervention/treatment Phase
Myeloma Drug: lenalidomide Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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).
Study Start Date : June 2006
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Assess the impact of Revlimid® on the post-transplant complete response rate [ Time Frame: 2 years ]
  2. Compare survival without events and overall survival of patients in the lenalidomide arm with the control [ Time Frame: 2 years ]
  3. Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430365


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

Publications:
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 ( Other Grant/Funding Number: 0400401 )
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents