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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Elotuzumab (Biological); Bortezomib (Drug); Dexamethasone (Drug); Dexamethasone (Drug); Dexamethasone (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

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

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

Primary outcome:

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

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

Secondary outcome:

PFS hazard ration in the subgroup of subjects with at least one FcγRIIIa V allele

Difference in response rates between treatment arms in the overall population

Estimate the difference in response rates between arms in the subgroup of subjects with at least one FcγRIIIa V allele

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed. com. Please visit www. BMSStudyConnect. com for more information on clinical trial participation. 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

Locations and Contacts

Local Institution, Grenoble Cedex 9 38043, France

Local Institution, Le Mans 72037, France

Local Institution, Lille Cedex 59037, France

Local Institution, Nantes 44093, France

Local Institution, Paris 75571, France

Local Institution, Toulouse 31059, France

Local Institution, Vandoeuvre Les Nancy 54500, France

Local Institution, Ancona 60126, Italy

Local Institution, Bari 70124, Italy

Local Institution, Bologna 40138, Italy

Local Institution, Brescia 25123, Italy

Local Institution, Firenze 50139, Italy

Local Institution, Genova 16132, Italy

Local Institution, Lecce 73100, Italy

Local Institution, Modena 41124, Italy

Local Institution, Pescara 65124, Italy

Local Institution, Ravenna 48121, Italy

Local Institution, Rimini 47014, Italy

Local Institution, Rimini 47900, Italy

Local Institution, Roma 00168, Italy

Local Institution, Roma 161, Italy

Local Institution, Rome 00144, Italy

Local Institution, Torino 10126, Italy

Local Institution, Barcelona 08003, Spain

Local Institution, Madrid 28006, Spain

Local Institution, Murcia 30008, Spain

Local Institution, Salamanca 37007, Spain

Local Institution, Santiago Compostela 15706, Spain

Local Institution, Toledo 45004, Spain

Local Institution, Valencia 46010, Spain

Local Institution, Valencia 46026, Spain

Local Institution, Zaragoza 50009, Spain

Compassionate Cancer Care Medical Group Inc, Corona, California 92879, United States

Local Institution, Corona, California 92879, United States

Local Institution, Long Beach, California 90806, United States

Ucla Department Of Medicine, Los Angeles, California 90095, United States

Usc Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States

Medical Oncology Care Associates, Orange, California 92868, United States

Sharp Clinical Oncology Research, San Diego, California 92123, United States

Kaiser Permanente Medical Center, Vallejo, California 94589, United States

Local Institution, Vallejo, California 94589, United States

Cancer Specialists Of North Florida Beaches, Jacksonville, Florida 32256, United States

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida 33140, United States

Palm Beach Cancer Institute, West Palm Beach, Florida 33401, United States

Kaiser Permanente-Moanalua Medical Center, Honolulu, Hawaii 96819, United States

University Of Chicago Medical Center, Chicago, Illinois 60637, United States

Local Institution, Decatur, Illinois 62526, United States

Oncology Specialists, S.C., Park Ridge, Illinois 60068, United States

Local Institution, Urbana, Illinois 61801, United States

Investigative Clinical Research Of Indiana, Llc, Indianapolis, Indiana 46260, United States

Local Institution, Hazard, Kentucky 41701, United States

University Of Kentucky Markey Cancer Center, Lexington, Kentucky 40536, United States

Pikeville Medical Center, Pikeville, Kentucky 41501, United States

Cancer Center Of Acadiana, Lafayette, Louisiana 70503, United States

Local Institution, Shreveport, Louisiana 71101, United States

Local Institution, Baltimore, Maryland 21204, United States

Dana Faber Cancer Institute, Boston, Massachusetts 02215, United States

Local Institution, Worcester, Massachusetts 01608, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Washington University School Of Medicine, Saint Louis, Missouri 63110, United States

Mercy Medical Research Institute, Springfield, Missouri 65807, United States

Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Waverly Hematology Oncology, Cary, North Carolina 27518, United States

Local Institution, Halifax, Nova Scotia B3H 2Y9, Canada

Local Institution, Milano, Parma 20132, Italy

Local Institution, Roma, Parma 00144, Italy

St. Agnes Hospital, Baltimore, Pennsylvania 21229, United States

Cancer Care Associates, Bethlehem, Pennsylvania 18015, United States

Penn State Hershey Cancer Inst, Hershey, Pennsylvania 17033, United States

Penn State Hershey Cancer Institute, Hershey, Pennsylvania 17033, United States

The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224, United States

Medical University Of South Carolina, Charleston, South Carolina 29425, United States

Local Institution, Greenville, South Carolina 29615, United States

Charles A. Sammons Cancer Center, Dallas, Texas 75246, United States

Northwest Cancer Center, Houston, Texas 77090, United States

Local Institution, Fairfax, Virginia 22031, United States

Local Institution, Seattle, Washington 98108, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: November 2011
Last updated: August 19, 2015

Page last updated: August 23, 2015

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