Myeloma
Conditions
Keywords
Myeloma, Revlimid, Maintenance therapy, Autologous Stem Cell Transplantation
Brief summary
Maintenance treatment of myeloma.
Interventions
DRUGlenalidomide
oral drug
DRUGplacebo
oral placebo
Sponsors
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Assess the impact of Revlimid® on the post-transplant complete response rate | 2 years |
| Compare survival without events and overall survival of patients in the lenalidomide arm with the control | 2 years |
| Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. | 3 years |
Countries
Belgium, France, Switzerland
Contacts
PRINCIPAL_INVESTIGATORATTAL Michel, Pr
University Hospital, Toulouse
Outcome results
None listed