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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 MedicineSaint Louis, Missouri  63110
Carle Cancer CenterUrbana, Illinois  61801
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Medical Oncology Care AssociatesOrange, California  92668
University of Chicago Medical CenterChicago, Illinois  60637
Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Local InstitutionCorona, California  
Local InstitutionHamden, Connecticut  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionArlington, Virginia  
Local InstitutionNew Orleans, Louisiana  
Kentucky Cancer ClinicPikeville, Kentucky  41501
Sharp Clinical Oncology ResearchSan Diego, California  92123
Compassionate Cancer Care Medical Group, IncFountain Valley, California  92708
Local InstitutionChattanooga, Tennessee  
Local InstitutionLittle Rock, Arkansas  
Local InstitutionIowa City, Iowa  
Local InstitutionLouisville, Kentucky  
Local InstitutionDetroit, Michigan  
Local InstitutionHonolulu, Hawaii  
Local InstitutionLas Vegas, Nevada  
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Cancer Care Specialists of Central IllinoisDecatur, Illinois  62256
Northwest Cancer CenterHouston, Texas  77042
UCLA Department of MedicineLos Angeles, California  90005
Mercy Medical Research InstituteSpringfield, Missouri  65807
Cancer Center Of AcadianaLafayette, Louisiana  70503
Reliant Medical Group, IncWorcester, Massachusetts  01608