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
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MLN9708; Lenalidomide; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Lenalidomide; Ixazomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma