Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).

Key facts

Study ID

NCT00920855

Run by

Cephalon

People needed

40

Starts

2009-06-01

Expected to finish

2011-12-01

Last updated by the study team

2012-10-04

Who can join

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

You may qualify if…

• The patient:
• has a diagnosis of multiple myeloma.
• currently has multiple myeloma with measurable disease.
• must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
• if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
• if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
• must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than 2.
• must have a life-expectancy of greater than 3 months.
• must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.

You may not qualify if…

• The patient has:
• had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
• plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
• plasma cell leukemia.
• non-measurable multiple myeloma.
• Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
• previously participated in a Cephalon-sponsored clinical study with bendamustine.
• impaired cardiac function or clinically significant cardiac diseases.
• undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
• severe hypercalcemia.
• other concurrent severe and/or uncontrolled medical or psychiatric conditions.
• known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
• a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
• received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
• received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
• received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
• a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
• a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
• used an investigational drug within 1 month before the screening visit.

Where it is running

• Pacific Oncololgy & Hematology — Encinitas, California, United States
• Capitol Hematology Oncology — Roseville, California, United States
• University Of California, San Diego — San Diego, California, United States
• James R. Berenson, M.D., Inc. — West Hollywood, California, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Northshore University Health System — Evanston, Illinois, United States
• Alivin & Lois Lapidus Cancer Institute — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Sophia Gordon Cancer Center at Lahey Clinic — Burlington, Massachusetts, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Charleston Hematology Oncology, PA — Charleston, South Carolina, United States
• Family Cancer Center, PLLC — Collierville, Tennessee, United States
• Fairfax Northern Virginia Hematology Oncology — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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