Clinical trial NCT01478048: Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Official title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2011-11-23
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants
timeFrame: Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years
measure: Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants
timeFrame: Randomization until 111 events, up to May 2014, approximately 2 years
measure: 1 Year Progression-Free Survival Rate - Randomized Participants
timeFrame: Year 1 after last participant was randomized
Secondary outcomes:
measure: Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele
timeFrame: Randomization until 111 events, up to May 2014, approximately 2 years
measure: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants
timeFrame: Randomization until 111 events, up to May 2014, approximately 2 years
measure: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele
timeFrame: Randomization until 111 events, up to May 2014, approximately 2 years
Other outcomes:
Locations:
city: Corona
country: United States
facility: Compassionate Cancer Res Grp
state: California
city: Corona
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ucla Department Of Medicine
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Vallejo
country: United States
facility: Local Institution
state: California
city: Jacksonville
country: United States
facility: Cancer Specialists of North FL
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente-Moanalua Medical Center
state: Hawaii
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Decatur
country: United States
facility: Local Institution
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Urbana
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Hazard
country: United States
facility: Local Institution
state: Kentucky
city: Lexington
country: United States
facility: University Of Kentucky Markey Cancer Center
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center Leonard Lawson Cancer Center
state: Kentucky
city: Lafayette
country: United States
facility: Cancer Center Of Acadiana
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation
state: Nevada
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: Cancer Care Associates
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Cancer Inst
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Local Institution
state: Virginia
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Grenoble Cedex 9
country: France
facility: Local Institution
city: Le Mans
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Paris 12
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
state: Parma
city: Roma
country: Italy
facility: Local Institution
state: Parma
city: Ancona
country: Italy
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Lecce
country: Italy
facility: Local Institution
city: Meldola (fc)
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Pescara
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Santiago Compostela
country: Spain
facility: Local Institution
city: Toledo
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.