Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4 MAJESTEC-4

What's the purpose of this trial?

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

This trial is currently open and 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:

* Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
* Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
* Must not be intolerant to the starting dose of lenalidomide.
* Must not have received any maintenance therapy.
* Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
* Have clinical laboratory values within prespecified range.

Exclusion Criteria:

* Received any prior BCMA-directed therapy.
* Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
* Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
* Progressed on multiple myeloma therapy at any time prior to screening.
* Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
* Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Additional Trial Information

Phase 3

Enrollment: 1,594 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Cancer Center

Tucson, AZ

Open and Accepting

California

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Florida Hospital Medical Center

Orlando, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Illinois

University of Illinois at Chicago

Chicago, IL

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Missouri

Siteman Cancer Center at Barnes-Jewish West County Hospital

Creve Coeur, MO

Open and Accepting

New York

New York Oncology Hematology - Albany Cancer Center

Albany, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

East Carolina University Vidant Cancer Care Eddie and Jo Allison Smith Tower

Greenville, NC

Open and Accepting

Ohio

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Open and Accepting

University of Cincinnati College of Medicine George L. Strike Bone Marrow Transplant Program

Cincinnati, OH

Open and Accepting

University Hospitals Seidman Cancer Center Seidman Cancer Center at UH Case Medical

Cleveland, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Pennsylvania

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Open and Accepting

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

Philadelphia, PA

Open and Accepting

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Open and Accepting

South Carolina

Gibbs Cancer Center and Research Spartanburg Medical Center

Spartanburg, SC

Open and Accepting

South Dakota

Avera Cancer Institute - Sioux Falls

Sioux Falls, SD

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

Texas Oncology - Austin Midtown

Austin, TX

Open and Accepting

Texas Oncology El Paso Cancer Treatment Center

El Paso, TX

Open and Accepting

Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center

Houston, TX

Open and Accepting

Utah

Intermountain Healthcare - LDS Hospital Intermountain Precision Genomics Cancer Research Clinic

Salt Lake City, UT

Open and Accepting

Virginia

Virginia Cancer Specialists

Fairfax, VA

Open and Accepting

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Open and Accepting

Washington

Swedish Medical Center (Ballard Campus)

Seattle, WA

Open and Accepting

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Open and Accepting

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting

Green Bay Oncology (HSHS St. Vincent Hospital) Saint Vincent Hospital

Green Bay, WI

Open and Accepting

Froedtert Memorial Lutheran Hospital

Milwaukee, WI

Open and Accepting
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