Phase 3 Clinical Trial Comparing Iberdomide VS Lenalidomide as Maintenance Therapy Following Autologous Stem Cell Transplant in Participants with Newly Diagnosed Multiple Myeloma EXCALIBER-MAINTENANCE
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What's the purpose of this trial?

The goal of this clinical trial is to learn more about the safety and efficacy of an investigational drug called Iberdomide when used as maintenance therapy, and to compare its safety and efficacy to Lenalidomide maintenance therapy. 

This trial has temporarily put patient recruitment on hold.

What will happen during the trial?

Participation in this study will be randomized, which means the study team will randomly place participants into one of several different groups. This trial is open-label, which means that both researchers and participants will know which groups they are placed in, and which medications and doses they will be receiving.  

This trial is organized into two different parts, or stages. In Stage 1, researchers will compare the safety and efficacy of three different dose levels of investigational drug Iberdomide to the standard maintenance treatment of Lenalidomide. Participants in this stage will be randomly assigned into one of four different arms (or groups). Three arms (A1, A2, and A3) will receive one of three different doses of investigational drug Iberdomide. The fourth group will receive Lenalidomide. 

In Stage 2, researchers will compare the safety and efficacy of investigational Iberdomide (using the dose from Stage 1) versus Lenalidomide. Participants in this stage will be randomly assigned into one of two different arms (Arms A and B). Participants in either part of the study can continue to receive the treatment they were randomized to as long as their myeloma remains stable or improves, and they don’t experience important side effects.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

• have measurable disease as defined by the trial criteria.
• have received 3-6 cycles of induction therapy, including a proteasome inhibitor and immunomodulatory agent (VTD [bortezomib, thalidomide, dexamethasone], RVd [lenalidomide, bortezomib, dexamethasone]) with or without a CD38 monoclonal antibody, or VCd (bortezomib, cyclophosphamide, dexamethasone) and followed by an autologous stem cell transplant. Participants are allowed to have received consolidation therapy after transplant.
• must be within 12 months from start of induction therapy, and have achieved at least a partial response after stem cell transplant.
• do not have known myeloma involvement in the central nervous system.
• have adequate bone marrow, kidney, and liver function.

Additional Trial Information

Phase 3

Enrollment: 1,216 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Recruitment on Hold

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Recruitment on Hold

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Recruitment on Hold

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Recruitment on Hold

Cleveland Clinic Florida

Weston, FL

Recruitment on Hold

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Recruitment on Hold

University Cancer and Blood Center

Athens, GA

Recruitment on Hold

Augusta University Medical Center

Augusta, GA

Recruitment on Hold

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Recruitment on Hold

Kansas

University of Kansas Cancer Center

Kansas City, KS

Recruitment on Hold

Maryland

Maryland Oncology Hematology (Clinton)

Clinton, MD

Recruitment on Hold

Massachusetts

University of Massachusetts Medical School

Worcester, MA

Recruitment on Hold

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Recruitment on Hold

Henry Ford Hospital

Detroit, MI

Recruitment on Hold

Mercy Health Cancer and Hematology Centers of West Michigan Lacks Cancer Center

Grand Rapids, MI

Recruitment on Hold

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Recruitment on Hold

Missouri

HCA Midwest Health Research Medical Center

Kansas City, MO

Recruitment on Hold

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Recruitment on Hold

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Recruitment on Hold

New York

New York University Langone Medical Center Laura and Isaac Perlmutter Cancer Center

New York, NY

Recruitment on Hold

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Recruitment on Hold

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Recruitment on Hold

Duke Cancer Center Duke University Medical Center

Durham, NC

Recruitment on Hold

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Recruitment on Hold

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Recruitment on Hold

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Recruitment on Hold

Cleveland Clinic (Fairview Hospital)

Cleveland, OH

Recruitment on Hold

Cleveland Clinic (Hillcrest Hospital)

Mayfield Heights, OH

Recruitment on Hold

Toledo Clinic Cancer Centers - Toledo

Toledo, OH

Recruitment on Hold

Cleveland Clinic - Wooster Family Health Center

Wooster, OH

Recruitment on Hold

Oregon

Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Recruitment on Hold

Pennsylvania

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Recruitment on Hold

Thomas Jefferson University Hospital

Philadelphia, PA

Recruitment on Hold

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Recruitment on Hold

Tennessee

West Cancer Center (East Campus - Germantown) East Campus

Germantown, TN

Recruitment on Hold

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Recruitment on Hold

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Recruitment on Hold

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Recruitment on Hold

MD Anderson Cancer Center The University of Texas

Houston, TX

Recruitment on Hold
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