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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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."
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 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 ALT or 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 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
To determine the safety and toxicity of the bendamustine/melphalan regimen
Outcome Time Frame:
100 days post autologous stem cell transplant
Safety Issue:
Yes
Principal Investigator
Tsiporah Shore, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Institutional Review Board
Study ID:
0812010147
NCT ID:
NCT00916058
Start Date:
March 2009
Completion Date:
March 2012
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Autologous Stem Cell Transplant
- ASCT
- MM
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Weill Cornell Medical College | New York, New York 10021 |
