Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

Key facts

Study ID

NCT01177683

Run by

Sherif Farag, MB, BS

People needed

32

Starts

2010-07-01

Expected to finish

2017-12-01

Last updated by the study team

2023-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
• Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain.
• Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
• Must be willing to provide correlative blood samples.

You may not qualify if…

• Must not have received an excessive cumulative dose of anthracycline
• No ≥ grade 2 peripheral neuropathy.
• No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
• No autologous stem cell transplant within 6 months prior to registration for protocol therapy
• No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.
• No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
• No known central nervous system involvement by myeloma.
• No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
• No patients known to be positive for HIV, or active Hepatitis A, B, or C.
• No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• IU Health Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• IU Health Arnett Cancer Center — Lafayette, Indiana, United States
• Metro Health Cancer Care — Wyoming, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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