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

July 8, 2019 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Acrc/Arizona Clinical Research Center, Inc.
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highland Oncology Group
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Encinitas, California, United States, 92024
        • California Cancer Associates for Research and Excellence
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Res Grp
      • Fountain Valley, California, United States, 92708
        • Robert A. Moss, Md Facp, Inc.
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Center
      • Monterey, California, United States, 93940
        • Pacific Cancer Care
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • West Hills, California, United States, 91307
        • Wellness Oncology & Hematology
      • West Hollywood, California, United States, 90069
        • James R. Berenson, MD, Inc.
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers LLP
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Cancer Specialists of North Florida
      • Lakeland, Florida, United States, 33805
        • Center for Cancer Care & Research
      • Miami, Florida, United States, 33176
        • Baptist Health Medical Group Oncology
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists,S.C
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana, LLC
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Research, Inc
    • New York
      • New York, New York, United States, 10021
        • Clinical Research Alliance, Inc.
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System
      • Greenville, South Carolina, United States, 29607
        • St Francis Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology
      • Houston, Texas, United States, 77090
        • Local Institution
      • San Antonio, Texas, United States, 78229
        • Cancer Centers of South Texas
      • Tyler, Texas, United States, 75701
        • Blood & Cancer Center of East Texas
      • Weslaco, Texas, United States, 78596
        • Texas Oncology-McAllen South Second Street
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Blue Ridge Cancer Care
    • Washington
      • Olympia, Washington, United States, 98502
        • Vista Oncology Inc., PS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Elotuzumab + Lenalidomide/Dexamethasone
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
Drug: Lenalidomide
Other Names:
  • Revlimid
Drug: Dexamethasone
Drug: Elotuzumab
Other Names:
  • BMS-901608

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Time Frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
Time Frame: Date of first dose up to 60 days post last dose (approximately 4 years)
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.
Date of first dose up to 60 days post last dose (approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2014

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

July 11, 2018

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (ESTIMATE)

June 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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