drugset / Trial / NCT03168100

2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma

NCT03168100

Phase 2 Withdrawn University of Arkansas
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2017-10-01
Primary completion
2019-01-24
Completion
2019-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg Subcutaneous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Elotuzumab Monoclonal antibody 10 mg Intravenous
Subject Lenalidomide Other / unclassified 15 mg Oral

Indications