Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effectiveness of induction therapy with
lenalidomide and low dose dexamethasone followed by sequential low dose bortezomib followed
by low dose Melphalan and Prednisone, then followed by low dose lenalidomide for multiple
cycles in subjects with high risk Multiple Myeloma (MM). The primary objective is to evaluate
the efficacy as measured by the progression free survival (PFS) at 2 years of low dose
sequential therapy following four cycles of induction therapy with lenalidomide/low-dose
dexamethasone in subjects with symptomatic high risk multiple myeloma, who have received no
prior treatment. A total of 35 subjects were estimated to be accrued to this Phase II trial
over a period of subjects who are still progression-free at 2 years. Two years will be as
measured from date of registration to the trial. Progression will include disease progression
(DP) as well as death due to any cause. Data will be analyzed and reported by the PI after 1
and 2 years of initiation of the study. All subsequent data collected may be analyzed and
reported in a follow-up clinical report. The PI and independent reviewers will meet to review
the efficacy and safety data and determine a risk/benefit analysis in this subject
population.