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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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elotuzumab
Lenalidomide
Dexamethasone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Acrc/Arizona Clinical Research Center, Inc.
  • Highland Oncology Group
  • Comprehensive Blood And Cancer Center
  • California Cancer Associates for Research and Excellence
  • Compassionate Cancer Res Grp
  • Robert A. Moss, Md Facp, Inc.
  • Loma Linda University Cancer Center
  • Pacific Cancer Care
  • Ventura County Hematology-Oncology Specialists
  • Wellness Oncology & Hematology
  • James R. Berenson, MD, Inc.
  • Rocky Mountain Cancer Centers Llp
  • Cancer Specialists Of North Florida
  • Center For Cancer Care & Research
  • Baptist Health Medical Group Oncology
  • Oncology Specialists,S.C
  • Investigative Clinical Research Of Indiana, Llc
  • Horizon Oncology Research, Inc
  • Clinical Research Alliance, Inc.
  • St Francis Hospital
  • Greenville Health System
  • Texas Oncology
  • Baylor Charles A. Sammons Cancer Center
  • Local Institution
  • Cancer Centers of South Texas
  • Blood & Cancer Center of East Texas
  • Texas Oncology-McAllen South Second Street
  • Blue Ridge Cancer Care
  • Vista Oncology Inc., PS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elotuzumab + Lenalidomide/Dexamethasone

Arm Description

Elotuzumab 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
An infusion reaction in this study is 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.

Full Information

First Posted
June 6, 2014
Last Updated
July 8, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02159365
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2014 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elotuzumab + Lenalidomide/Dexamethasone
Arm Type
Experimental
Arm Description
Elotuzumab 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
Intervention Type
Drug
Intervention Name(s)
Elotuzumab
Other Intervention Name(s)
BMS-901608
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Description
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.
Time Frame
From Day 1 to End of cycle 2 treatment (approximately 56 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
Description
An infusion reaction in this study is 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.
Time Frame
Date of first dose up to 60 days post last dose (approximately 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Acrc/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Highland Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Comprehensive Blood And Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Compassionate Cancer Res Grp
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Robert A. Moss, Md Facp, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Wellness Oncology & Hematology
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
James R. Berenson, MD, Inc.
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Rocky Mountain Cancer Centers Llp
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Cancer Specialists Of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Center For Cancer Care & Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Baptist Health Medical Group Oncology
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Oncology Specialists,S.C
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Investigative Clinical Research Of Indiana, Llc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Horizon Oncology Research, Inc
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Clinical Research Alliance, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Cancer Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Blood & Cancer Center of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Texas Oncology-McAllen South Second Street
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Vista Oncology Inc., PS
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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