Expanded Access Treatment Protocol CA204-143

November 29, 2023 updated by: Bristol-Myers Squibb

An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

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
    • California
      • Concord, California, United States, 94520
        • John Muir Medical Center
      • Corona, California, United States, 92879
        • Compassionate Cancer Res Grp
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92093-0698
        • UC San Diego Moores Cancer Ctr
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • Los Angeles, California, United States, 90095
        • Central Coast Med Oncology
      • Redondo Beach, California, United States, 90277
        • Torrance Health Association
      • Solvang, California, United States, 93463
        • Sansum Santa Barbara Medical Foundation Clinic
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Hospital Med Ctr
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02114
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Beth Israel Deaconess Medical Center (BIDMC)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • East Setauket, New York, United States, 11733
        • North Shore Hematology/Oncology Associates, P.C.
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital-Weill Cornell Med College
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute At The Univ. Of Utah
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Wellmont Medical Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute

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

N/A

Description

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

Inclusion Criteria

  • Men and women 18 years and older.
  • Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy.

  • Prior lenalidomide exposure is permitted only if they fulfill all of the following:.

    i) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.

A. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria

  • Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
  • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
  • Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
  • HIV infection or active hepatitis A, B, or C.
  • History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009.
  • Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD).
  • Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
  • Certain abnormal physical or laboratory findings.
  • Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

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?

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, 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 Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimated)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-143

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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