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 :
Completed
First Posted : February 1, 2007
Last Update Posted : April 26, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myeloma | Drug: lenalidomide Drug: placebo | Phase 3 |
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). |
Actual Study Start Date : | June 2006 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2018 |
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 |
- Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ]
- Assess the impact of Revlimid® on the post-transplant complete response rate [ Time Frame: 2 years ]
- Compare survival without events and overall survival of patients in the lenalidomide arm with the control [ Time Frame: 2 years ]
- Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. [ Time Frame: 3 years ]
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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.
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
Principal Investigator: | ATTAL Michel, Pr | University Hospital, Toulouse |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT00430365 |
Other Study ID Numbers: |
0400401 French PHRC ( Other Grant/Funding Number: 0400401 ) |
First Posted: | February 1, 2007 Key Record Dates |
Last Update Posted: | April 26, 2019 |
Last Verified: | April 2019 |
Myeloma Revlimid Maintenance therapy Autologous Stem Cell Transplantation |
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 Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |