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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |