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 has temporarily put patient recruitment on hold.

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

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Arizona

University of Arizona Cancer Center

Tucson, AZ

Recruitment on Hold

California

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Recruitment on Hold

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Recruitment on Hold

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

Denver, CO

Recruitment on Hold

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Recruitment on Hold

Delaware

Christiana Care Health System (Christiana Hospital)

Newark, DE

Recruitment on Hold

Florida

Florida Hospital Medical Center

Orlando, FL

Recruitment on Hold

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Recruitment on Hold

Illinois

University of Illinois at Chicago

Chicago, IL

Recruitment on Hold

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Recruitment on Hold

Maryland

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

Baltimore, MD

Recruitment on Hold

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Recruitment on Hold

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Recruitment on Hold

Beth Israel Deaconess Medical Center

Boston, MA

Recruitment on Hold

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Recruitment on Hold

Missouri

Siteman Cancer Center at Barnes-Jewish West County Hospital

Creve Coeur, MO

Recruitment on Hold

New York

New York Oncology Hematology - Albany Cancer Center

Albany, NY

Recruitment on Hold

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Recruitment on Hold

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Recruitment on Hold

North Carolina

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Recruitment on Hold

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

Charlotte, NC

Recruitment on Hold

Duke Cancer Center Duke University Medical Center

Durham, NC

Recruitment on Hold

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

Greenville, NC

Recruitment on Hold

Ohio

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Recruitment on Hold

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

Cincinnati, OH

Recruitment on Hold

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

Cleveland, OH

Recruitment on Hold

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

Columbus, OH

Recruitment on Hold

Pennsylvania

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Recruitment on Hold

Penn State Hershey Medical Center

Hershey, PA

Recruitment on Hold

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Recruitment on Hold

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

Philadelphia, PA

Recruitment on Hold

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Recruitment on Hold

Gibbs Cancer Center and Research Spartanburg Medical Center

Spartanburg, SC

Recruitment on Hold

South Dakota

Avera Cancer Institute - Sioux Falls

Sioux Falls, SD

Recruitment on Hold

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Recruitment on Hold

Texas

Texas Oncology - Austin Midtown

Austin, TX

Recruitment on Hold

Texas Oncology El Paso Cancer Treatment Center

El Paso, TX

Recruitment on Hold

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

Houston, TX

Recruitment on Hold

Utah

Intermountain Healthcare - LDS Hospital Intermountain Precision Genomics Cancer Research Clinic

Salt Lake City, UT

Recruitment on Hold

Virginia

Virginia Cancer Specialists

Fairfax, VA

Recruitment on Hold

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Recruitment on Hold

Washington

Swedish Medical Center (Ballard Campus)

Seattle, WA

Recruitment on Hold

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

Seattle, WA

Recruitment on Hold

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Recruitment on Hold

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

Green Bay, WI

Recruitment on Hold

Froedtert Memorial Lutheran Hospital

Milwaukee, WI

Recruitment on Hold
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