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 is currently open and accepting patients.

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

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Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Open and Accepting

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Tampa General Hospital Cancer Institute

Tampa, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Cleveland Clinic Florida

Weston, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

University Cancer and Blood Center

Athens, GA

Open and Accepting

Augusta University Medical Center

Augusta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Maryland

Maryland Oncology Hematology (Clinton)

Clinton, MD

Open and Accepting

Massachusetts

University of Massachusetts Medical School

Worcester, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

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

Grand Rapids, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Open and Accepting

Missouri

HCA Midwest Health Research Medical Center

Kansas City, MO

Open and Accepting

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

Open and Accepting

New York

Clinical Research Alliance

Lake Success, NY

Open and Accepting

NYU Langone - Long Island

Mineola, NY

Open and Accepting

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

New York, NY

Open and Accepting

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

New York, NY

Open and Accepting

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Cleveland Clinic (Fairview Hospital)

Cleveland, OH

Open and Accepting

Cleveland Clinic (Hillcrest Hospital)

Mayfield Heights, OH

Open and Accepting

Toledo Clinic Cancer Centers - Toledo

Toledo, OH

Open and Accepting

Cleveland Clinic - Wooster Family Health Center

Wooster, OH

Open and Accepting

Oregon

Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Open and Accepting

Pennsylvania

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Recruitment on Hold

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

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

Pittsburgh, PA

Open and Accepting

Tennessee

West Cancer Center (East Campus - Germantown) East Campus

Germantown, TN

Open and Accepting

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

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

Dallas, TX

Open and Accepting

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

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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