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)

View More
Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Banner Health University Medical Center

Tucson, AZ

Not Yet Accepting

University of Arizona Cancer Center

Tucson, AZ

Not Yet Accepting

California

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Not Yet Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Not Yet 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

Delaware

Christiana Care Health System (Christiana Hospital)

Newark, DE

Open and Accepting

Florida

Florida Hospital Medical Center

Orlando, FL

Not Yet Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Illinois

University of Illinois at Chicago

Chicago, IL

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

Not Yet Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Not Yet Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

North Carolina

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

Charlotte, NC

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

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

Greenville, NC

Not Yet Accepting

Ohio

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

OhioHealth Riverside Methodist Hospital

Columbus, OH

Not Yet Accepting

Pennsylvania

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Open and Accepting

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Open and Accepting

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

Philadelphia, PA

Open and Accepting

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Not Yet Accepting

Gibbs Cancer Center and Research Spartanburg Medical Center

Spartanburg, SC

Not Yet Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

Houston Methodist Hospital

Houston, TX

Not Yet Accepting

Virginia

Virginia Oncology Associates

Newport News, VA

Open and Accepting

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Open and Accepting

Washington, D.C.

Sibley Memorial Hospital The Johns Hopkins Hospital

Washington, DC

Not Yet 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
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • Add this trial to your favorites keyboard_arrow_right

    If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message