Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT01484626
Run by: Loyola University
People needed: 3
Starts: 2011-05-05
Expected to finish: 2014-06-18
Last updated by the study team: 2018-07-10

Who can join

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

You may qualify if…

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

You may not qualify if…

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

Where it is running

Loyola University Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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