Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
1 other identifier
interventional
84
1 country
29
Brief Summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Mar 2014
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2014
CompletedFirst Submitted
Initial submission to the registry
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedResults Posted
Study results publicly available
January 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2018
CompletedJuly 16, 2019
July 1, 2019
2.3 years
June 6, 2014
November 15, 2016
July 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
From Day 1 to End of cycle 2 treatment (approximately 56 days)
Secondary Outcomes (1)
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
Date of first dose up to 60 days post last dose (approximately 4 years)
Study Arms (1)
Elotuzumab + Lenalidomide/Dexamethasone
EXPERIMENTALElotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
Interventions
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Documented evidence of active multiple myeloma:
- Newly diagnosed, not candidate for transplant
- Relapsed/refractory who have received up to 3 prior lines of therapy
- Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
- Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
- Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
You may not qualify if:
- Target Disease Exceptions
- Plasma cell leukemia
- Monoclonal gammopathy of undetermined significance (MGUS)
- Smoldering Myeloma
- Primary amyloidosis
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715, United States
Highland Oncology Group
Fayetteville, Arkansas, 72703, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309, United States
California Cancer Associates for Research and Excellence
Encinitas, California, 92024, United States
Compassionate Cancer Res Grp
Fountain Valley, California, 92708, United States
Robert A. Moss, Md Facp, Inc.
Fountain Valley, California, 92708, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
Pacific Cancer Care
Monterey, California, 93940, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wellness Oncology & Hematology
West Hills, California, 91307, United States
James R. Berenson, MD, Inc.
West Hollywood, California, 90069, United States
Rocky Mountain Cancer Centers Llp
Denver, Colorado, 80218, United States
Cancer Specialists Of North Florida
Jacksonville, Florida, 32204, United States
Center For Cancer Care & Research
Lakeland, Florida, 33805, United States
Baptist Health Medical Group Oncology
Miami, Florida, 33176, United States
Oncology Specialists,S.C
Park Ridge, Illinois, 60068, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, 47905, United States
Clinical Research Alliance, Inc.
New York, New York, 10021, United States
St Francis Hospital
Greenville, South Carolina, 29607, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
Texas Oncology
Dallas, Texas, 75231, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Local Institution
Houston, Texas, 77090, United States
Cancer Centers of South Texas
San Antonio, Texas, 78229, United States
Blood & Cancer Center of East Texas
Tyler, Texas, 75701, United States
Texas Oncology-McAllen South Second Street
Weslaco, Texas, 78596, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Vista Oncology Inc., PS
Olympia, Washington, 98502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2014
First Posted
June 9, 2014
Study Start
March 8, 2014
Primary Completion
June 30, 2016
Study Completion
July 11, 2018
Last Updated
July 16, 2019
Results First Posted
January 11, 2017
Record last verified: 2019-07