Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma

• Status: Terminated
• Trial end date: 2014-06-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined, phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.

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

Details

• Lead Sponsor: Loyola University
• Collaborator: Celgene
• Treatments: BB 1101; Bendamustine Hydrochloride; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy

• Must have adequate liver and renal function

• Zubrod Performance Status (ZPS) of 2 or better

• Must have measurable disease

Exclusion Criteria:

• Peripheral neuropathy of grade II or higher

• Thrombocytopenia (platelets less than 50,000/uL)

• Neutropenia (ANC<1000/uL)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.4 X ULN

• Total bilirubin >1.5 X upper limit of normal (ULN)

• Creatinine clearance of less than 45 milliliters per minute (mL/min)

• Patients with HIV

• Patients with active hepatitis

• Pregnant or lactating women

• Individuals of child-bearing potential not using adequate contraception

• Individuals unable to provide informed consent