Multiple Myeloma Clinical Trial
This protocol is a randomized, open-label, national, multicenter trial studying maintenance
treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708
after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed
symptomatic multiple myeloma.
A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study.
The pre-treatment period includes the screening visit in which participants provide informed
consent in writing in order to take part in the study. The patient is then assessed to
determine his/her eligibility. The selection process will begin 21 days before the first dose
of medication is administered (days -21 to 0). All procedures during the pre-treatment period
will be carried out after completion of the two cycles of post-transplant consolidation with
VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65.
During the treatment period, eligible patients will be included in the study and receive
maintenance treatment with lenalidomide/dexamethasone versus
lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will
consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day
of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B of
the maintenance treatment will be the same as arm A, with the addition of MLN9708 during the
two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle.
At two years, patients with negative MRD will finish maintenance treatment. Patients with
positive MRD will continue treatment with lenalidomide/dexamethasone until they have
completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will
only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be adjusted.
(unless necessary to treat adverse events)
Once this phase of active treatment is complete, patients will begin the long-term follow-up
phase, during which they will be visited every three months to evaluate progression and
survival.
The primary trial objectives are:
• Impact on progression-free survival (PFS) when adding MLN9708 to post-transplant
maintenance treatment with lenalidomide/dexamethasone in patients with multiple myeloma.
The secondary trial objectives are:
- Evaluate development and clinical significance of minimal residual disease (MRD) from
the time maintenance treatment is initiated, yearly over five years.
- Overall survival (OS).
- Evaluate the safety and tolerability of the maintenance treatment.
;
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