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The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients. However, some patients still relapse early during maintenance treatment meaning that better options are still needed. This study will evaluate a treatment regimen that alternates two different 3-drug regimens every eight weeks for patients that have previously completed autologous stem cell transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will be measured by the depth of response (i.e., whether or not minimal residual disease (MRD) negative status is achieved). The rate of MRD negativity from this study will be compared to historical control data from the Total Therapy 4 trial which used continuous VRD maintenance therapy after stem cell transplant(s).
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Inclusion criteria
Patients must be at least 18 years of age and not older than 75 years of age at the time of enrollment.
Patients must have completed a stem cell transplant regimen for newly diagnosed multiple myeloma (MM) consisting of (at least) induction chemotherapy and single or tandem autologous stem cell transplant (ASCT) within eight months of study enrollment. The completed regimen may have included post-transplant consolidation therapy, but post-transplant consolidation is not required.
Patients must have achieved at least a partial response (PR) (according to International Myeloma Working Group (IMWG) criteria) in response to the completed transplant regimen.
ECOG ≤ 2 (ECOG of 3 allowed if solely due to symptoms of MM-related bone disease).
Patients must have absolute neutrophil count (ANC) ≥ 1,000/mm3 and a platelet count of ≥ 75,000/μL.
Patients must have a baseline serum creatinine level of < 3 mg/dL and baseline alanine aminotransferase (ALT) < 3x Upper limit of normal (ULN)
Toxicities related to prior therapies must be resolved to ≤ Grade 2 according to NCI Common Terminology for Adverse Events (CTCAE) Version 4.
Female patients must be:
Male patients, even if surgically sterilized (ie, post-vasectomy) must agree to one of the following:
Patients must sign an Institutional Review Board (IRB)-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.
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Data sourced from clinicaltrials.gov
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