Overview

This trial is active, not recruiting.

Condition myeloma
Treatments lenalidomide, placebo
Phase phase 3
Sponsor University Hospital, Toulouse
Collaborator Intergroupe Francophone du Myelome
Start date June 2006
End date September 2016
Trial size 614 participants
Trial identifier NCT00430365, 0400401, French PHRC

Summary

Maintenance treatment of myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Administration of oral placebo
placebo
oral placebo
(Experimental)
Administration of lenalidomide
lenalidomide REVLIMID
oral drug

Primary Outcomes

Measure
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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).
Principal investigator ATTAL Michel, Pr
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University Hospital, Toulouse.