Multiple Myeloma Clinical Trial
Official title:
Phase 1 Study of Elotuzumab in Combination With Autologous Stem Cell Transplantation and Lenalidomide Maintenance for Multiple Myeloma
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.
This is a Phase 1b, open-label, trial investigating elotuzumab and autologous PBMC
reconstitution with auto-SCT consolidation therapy and lenalidomide maintenance. Fifteen
patients will be enrolled in this study.
This study is based on the hypothesis that the addition of Elotuzumab and autologous PBMC
reconstitution to standard-of-care auto-SCT and lenalidomide maintenance will be safe and
feasible. Furthermore, we hypothesize that Elotuzumab and PBMC reconstitution will target
residual myeloma cells, enhance NK cell activation and ADCC, and promote tumor-specific
humoral and cellular immune responses against myeloma cells, resulting in long-term
maintenance of the minimal residual disease state.
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