Clinical trial NCT00920855: Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
Official title: An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Participants With Dose Limiting Toxicity (DLT)
timeFrame: Day 1 - 28
Secondary outcomes:
measure: Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator
timeFrame: Up to 7.5 months (eight 28-day cycles)
measure: Participants' Best Tumor Response as Assessed by the Investigator
timeFrame: up to 7.5 months (eight 28-day cycles)
measure: Kaplan-Meier Estimate for Time to Progression (TTP)
timeFrame: up to 8.6 months
measure: Kaplan-Meier Estimate for Progression-Free Survival
timeFrame: up to 23 months
measure: Time to the First Response
timeFrame: up to 8.5 months
measure: Kaplan-Meier Estimate for Duration of Response
timeFrame: up to 8.5 months
measure: Kaplan-Meier Estimate for Overall Survival (OS)
timeFrame: up to 23 months
measure: Summary of Participants With Adverse Events (AEs)
timeFrame: up to 8.5 months. Deaths are reported up to 18 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Pacific Oncololgy & Hematology
state: California
city: Roseville
country: United States
facility: Capitol Hematology Oncology
state: California
city: San Diego
country: United States
facility: University Of California, San Diego
state: California
city: West Hollywood
country: United States
facility: James R. Berenson, M.D., Inc.
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Baltimore
country: United States
facility: Alivin & Lois Lapidus Cancer Institute
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Burlington
country: United States
facility: Sophia Gordon Cancer Center at Lahey Clinic
state: Massachusetts
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: Collierville
country: United States
facility: Family Cancer Center, PLLC
state: Tennessee
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology Oncology
state: Virginia
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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