Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma
Summary
The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year. Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks. An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced. The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.
Timeline
- Start
- 2016-01
- Primary completion
- 2017-07-13
- Completion
- 2017-07-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elotuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Lenalidomide | Other / unclassified | 10 mg | Oral |