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

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sherif Farag, MB, BS
• Collaborators: Cephalon; Hoosier Cancer Research Network
• Treatments: Bendamustine Hydrochloride; Bortezomib; Doxorubicin; Lenograstim; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.