Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™),
 in combination with Melphalan in subjects with multiple myeloma who are undergoing an
 Autologous Stem Cell Transplant.
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."
Inclusion Criteria:

 -  Patients with multiple myeloma who have received induction therapy and have had stem
 cells mobilized in preparation for autologous transplantation will be eligible for
 this study. Patients are also eligible with relapsed or refractory disease, after
 attempts at more standard approaches, and with the availability of stem cells.

 -  Patients must be age 18 or older.

 -  Patients must have a life expectancy of at least 12 weeks.

 -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
 0, 1 or 2.

 -  Patients must provide written informed consent.

 Exclusion Criteria:

 -  Impaired renal function with a measured or calculated creatinine clearance of less
 than 25 ml/min.

 -  Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of
 normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
 greater than 5 x ULN.

 -  Serious active or uncontrolled infection or medical condition.

 -  Women who are pregnant or breast feeding. Women of childbearing age must use adequate
 contraception and have a negative pregnancy test.

 -  Impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide
 (DLCO) less than 45% predicted.

 -  Impaired cardiac function with an ejection fraction less than 40% of predicted.

 -  Other systemic anticancer therapy or ongoing toxicities from such therapy.