Multiple Myeloma Clinical Trial
Official title:
A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma
This protocol is a national, multicenter, comparative, open-label, randomized trial comparing
the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL
versus. MEL-200).
A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits
will take place during the pre-treatment, treatment and follow-up periods.
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). During the treatment period, eligible patients
will be included in the study and given six cycles of induction treatment with bortezomib/
lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC
bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of
each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.
After the first three induction cycles, and in the absence of progression or unacceptable
toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using
G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation
ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take
place at the beginning of the study, once the screening is complete and the patient's
eligibility verified. Three months after transplantation, patients will receive two cycles of
consolidation treatment with VRD-GEM at the same doses administered during induction
treatment.
Once the treatment phase is complete, patients will begin the follow-up phase in which they
will be visited every three months to evaluate disease progression and survival
n/a
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