PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

June 29, 2021 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

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

  • Greece
      • Athens, Greece, 11528
        • Local Institution
  • Italy
      • Genova, Italy, 16132
        • Local Institution
      • Rome, Italy, 00161
        • Local Institution
  • Poland
      • Chorzow, Poland, 41-500
        • Local Institution
      • Lublin, Poland, 20-081
        • Local Institution
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan St. Francis Health
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Crescent City Research Consortium, LLC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hollings Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
    • Utah
      • Ogden, Utah, United States, 84405
        • Northern Utah Associates

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:

Subjects who are newly diagnosed with symptomatic MM and who:

  • Have not received any prior systemic anti-myeloma therapy
  • Have measurable disease
  • And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years old. There must be a comorbidity that prevents SCT for a subject <65 years old

Exclusion Criteria:

  • Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
  • Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Active plasma cell leukemia
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Lenalidomide + Dexamethasone

Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug

Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
Drug: Lenalidomide
Other Names:
  • Revlimid®
Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Experimental: Arm 2: Lenalidomide + Dexamethasone + Elotuzumab

Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)

Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)]

Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)]

Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)]

Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)]

Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond)

Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
Drug: Lenalidomide
Other Names:
  • Revlimid®
Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Biological: Elotuzumab
Other Names:
  • BMS-901608

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells
Time Frame: From baseline (screening) to time of progression (up to approximately 54 months)

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity.

The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)
From baseline (screening) to time of progression (up to approximately 54 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression
Time Frame: Time of progression (up to approximately 54 months from pre-treatment screening)

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression.

The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)
Time of progression (up to approximately 54 months from pre-treatment screening)
Levels of CS1 Soluble Form (sCS1) in Serum
Time Frame: At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months)
Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months)
Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression
Time Frame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)
Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)
Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells
Time Frame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
Circulating MM cells isolated from peripheral blood
From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells
Time Frame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
Circulating MM cells isolated from peripheral blood
From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells
Time Frame: At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months)
CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants
At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months)

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Abbott

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)

September 30, 2013

Primary Completion (Actual)

June 25, 2020

Study Completion (Actual)

June 25, 2020

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-006 (Biomarker Substudy)
  • 2010-022445-20 (EudraCT Number)

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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