Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
Completed · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT00916058
- Run by
- Weill Medical College of Cornell University
- People needed
- 57
- Starts
- 2009-04-23
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2019-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Weill Cornell Medical College — New York, New York, United States
Full record on ClinicalTrials.gov
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