A Phase 1 Pilot Study of a Novel Conditioning Regimen of Bendamustine and Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma
Bendamustine (TREANDA™) has been used in clinical trials to treat multiple myeloma. The
results from these trials suggest that it may be beneficial in the treatment of multiple
myeloma in a different treatment context. Researchers aim to determine if there may be an
improved benefit in the context of bone marrow transplant. This initial clinical trial is
intended to help determine how safe it is to use bendamustine as a conditioning regimen for
bone marrow transplant, and to look for any initial evidence of benefit.
Bendamustine (TREANDA™) is approved by the Food and Drug Administration (FDA) for the
treatment of Chronic Lymphocytic Leukemia and Melphalan is a type of chemotherapy drug.
The use of Melphalan alone as a conditioning regimen for Autologous Stem Cell Transplant is
considered "Standard of Care," that is, the treatment or process that your doctor would
normally follow to treat your disease. Although Bendamustine (TREANDA™) has been used in
multiple myeloma research studies, the combination of Bendamustine (TREANDA™) and Melphalan
as treatment for Multiple Myeloma is not approved by the FDA, thus the combination therapy
used in this research study is considered "investigational."
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
To determine the safety and toxicity of the bendamustine/melphalan regimen
100 days post autologous stem cell transplant
Tsiporah Shore, M.D.
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Cornell Medical College||New York, New York 10021|