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

NCT ID: NCT00920855

Last Updated: 2012-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

Brief Summary

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).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine and Bortezomib

Bendamustine in escalating doses of 50, 70 or 90 mg/m\^2 as combination therapy with bortezomib at 1.0 mg/m\^2/dose administered for up to eight 28 day cycles.

Group Type: EXPERIMENTAL

bendamustine

Intervention Type: DRUG

Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib.

Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle.

bortezomib

Intervention Type: DRUG

Bortezomib was administered at a dose of 1.0 mg/m\^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.

Interventions

bendamustine

Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib.

Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle.

Intervention Type: DRUG

bortezomib

Bortezomib was administered at a dose of 1.0 mg/m\^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

CEP-18083; Bendamustine hydrochloride; TREANDA; VELCADE®

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon

Locations

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

Countries

United States

References

Berenson JR, Yellin O, Bessudo A, et al. Bendamustine combined with bortezomib has efficacy in patients with relapsed or refractory multiple myeloma: a phase 1/2 study. Blood (ASH Annual Meeting Abstracts). 2011;118 (suppl 21):abstract 1857

Reference Type: RESULT

Other Identifiers

C18083/1063/MM/US

Identifier Type: -

Identifier Source: org_study_id