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An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants With Dose Limiting Toxicity (DLT)

Outcome Description:

Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle: grade 4 hematologic toxicity without regard for relationship to study drug treatment thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage grade 3 febrile neutropenia grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy any study drug related grade 3 or grade 4 nonhematologic toxicity any drug related death Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.

Outcome Time Frame:

Day 1 - 28

Safety Issue:

Yes

Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C18083/1063/MM/US

NCT ID:

NCT00920855

Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Geisinger Medical CenterDanville, Pennsylvania  17822-0001
University of California, San DiegoLa Jolla, California  92037-1709
George Washington UniversityWashington, District of Columbia  20037
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Family Cancer Center, PLLCCollierville, Tennessee  38017
NorthShore University health systemEvanston, Illinois  60201
Pacific Oncololgy & HematologyEncinitas, California  
Capitol Hematology OncologyRoseville, California  
James R. Berenson, M.D., Inc.West Hollywood, California  
Alivin & Lois Lapidus Cancer InstituteBaltimore, Maryland  
Sophia Gordon Cancer Center at Lahey ClinicBurlington, Massachusetts  
Fairfax Northern Virginia Hematology OncologyFairfax, Virginia