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A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma


Inclusion Criteria:



- Documented progression from most recent line of therapy

- Measurable disease

- 1 to 3 prior lines of therapy

- Subjects may be proteasome inhibitor naive or have received prior proteasome
inhibitor therapy provided all the following criteria are met:

1. The subject did not discontinue any proteasome inhibitor due to intolerance
or grade ≥ 3 toxicity

2. The subject is not refractory to any proteasome inhibitor, defined as
progression during treatment or within 60 days after the last dose

3. The subject previously achieved a partial response (PR) or better to
previous proteasome inhibitor (PI)

Exclusion Criteria:

- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or
Waldenstrom's macroglobulinemia

- Active plasma cell leukemia

- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause

Outcome Time Frame:

Every 21 +/-7 days (Cycles 1-8) relative to the first dose of study medication

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA204-009

NCT ID:

NCT01478048

Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed/Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110
Carle Cancer Center Urbana, Illinois  61801
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Greater Baltimore Medical Center Baltimore, Maryland  21204
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Medical Oncology Care Associates Orange, California  92668
University of Chicago Medical Center Chicago, Illinois  60637
Local Institution Chicago, Illinois  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Portland, Oregon  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
Oncology Specialists, S.C. Park Ridge, Illinois  60068
Local Institution Corona, California  
Local Institution Hamden, Connecticut  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Local Institution Wilmington, North Carolina  
Local Institution Duncansville, Pennsylvania  
Local Institution North Charleston, South Carolina  
Local Institution Austin, Texas  
Local Institution Arlington, Virginia  
Local Institution New Orleans, Louisiana  
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Sharp Clinical Oncology Research San Diego, California  92123
Compassionate Cancer Care Medical Group, Inc Fountain Valley, California  92708
Local Institution Chattanooga, Tennessee  
Local Institution Little Rock, Arkansas  
Local Institution Iowa City, Iowa  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan  
Local Institution Honolulu, Hawaii  
Local Institution Las Vegas, Nevada  
Investigative Clinical Research of Indiana, LLC Indianapolis, Indiana  46254
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Northwest Cancer Center Houston, Texas  77042
UCLA Department of Medicine Los Angeles, California  90005
Mercy Medical Research Institute Springfield, Missouri  65807
Cancer Center Of Acadiana Lafayette, Louisiana  70503
Reliant Medical Group, Inc Worcester, Massachusetts  01608