Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].

Key facts

Study ID

NCT01478048

Run by

Bristol-Myers Squibb

People needed

185

Starts

2011-11-30

Expected to finish

2017-04-21

Last updated by the study team

2018-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
• The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
• The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)

You may not qualify if…

• 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

Where it is running

• Local Institution — Corona, California, United States
• Local Institution — Long Beach, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Ucla Department Of Medicine — Los Angeles, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Kaiser Permanente Medical Center — Vallejo, California, United States
• Local Institution — Vallejo, California, United States
• Cancer Specialists of North FL — Jacksonville, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Kaiser Permanente-Moanalua Medical Center — Honolulu, Hawaii, United States
• University Of Chicago Medical Center — Chicago, Illinois, United States
• Local Institution — Decatur, Illinois, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Local Institution — Urbana, Illinois, United States
• Investigative Clinical Research Of Indiana, Llc — Indianapolis, Indiana, United States
• Local Institution — Hazard, Kentucky, United States
• University Of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Pikeville Medical Center Leonard Lawson Cancer Center — Pikeville, Kentucky, United States
• Cancer Center Of Acadiana — Lafayette, Louisiana, United States
• Local Institution — Shreveport, Louisiana, United States
• Local Institution — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Compassionate Cancer Res Grp — Corona, California, United States

Full record on ClinicalTrials.gov

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