A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

What's the purpose of this trial?

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

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.

Inclusion Criteria

* Confirmed diagnosis of symptomatic multiple myeloma (MM)
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2
* Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)\] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted
* Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria

Exclusion Criteria

* Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy
* Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma
* Known central nervous system/meningeal involvement of MM
* Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

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.

California

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, CA

Not Yet Accepting

Colorado

Rocky Mountain Cancer Centers - Denver Midtown Denver - Midtown

Denver, CO

Not Yet Accepting

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Not Yet Accepting

Woodlands Medical Specialists

Pensacola, FL

Not Yet Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Cleveland Clinic Florida

Weston, FL

Not Yet Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting

University Cancer and Blood Center

Athens, GA

Not Yet Accepting

Augusta University Medical Center

Augusta, GA

Not Yet Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Not Yet Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Not Yet Accepting

Maryland

Maryland Oncology Hematology (Clinton)

Clinton, MD

Not Yet Accepting

Massachusetts

University of Massachusetts Medical School

Worcester, MA

Not Yet Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Not Yet Accepting

Henry Ford Hospital

Detroit, MI

Not Yet Accepting

Ascension St. John Hospital Van Elslander Cancer Center

Grosse Pointe Woods, MI

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Not Yet Accepting

Missouri

HCA Midwest Health

Kansas City, MO

Not Yet Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Not Yet Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Not Yet Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Not Yet Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, NY

Not Yet Accepting

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

New York, NY

Not Yet Accepting

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Not Yet Accepting

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Not Yet Accepting

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Toledo Clinic Cancer Centers - Toledo

Toledo, OH

Not Yet Accepting

Oregon

Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Not Yet Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Not Yet Accepting

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Not Yet Accepting

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

Pittsburgh, PA

Not Yet Accepting

Cancer Care Associates of York

York, PA

Not Yet Accepting

Tennessee

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Not Yet Accepting

Tennessee Oncology Centennial Clinic

Nashville, TN

Not Yet Accepting

Texas

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

Dallas, TX

Not Yet Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Not Yet Accepting

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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