A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma MAJESTEC-2

What's the purpose of this trial?

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

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:

  • Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received at least 1 prior line of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb)
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level greater than or equal to (>=) 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligram (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >=10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment

Exclusion Criteria:

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA)
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment, unless approved by sponsor
  • Received a cumulative dose of corticosteroids equivalent to >= 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Known to be seropositive for human immunodeficiency virus

Additional Trial Information

Phase 1

Enrollment: 146 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center at UAB

Birmingham, AL

Open and Accepting

California

University of California San Francisco (Fresno Campus)

Fresno, CA

Open and Accepting

Colorado

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

Denver, CO

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Indiana

Indiana University Health Hematology & Oncology (North Hospital) IU Health North Hospital Medical Office Building

Carmel, IN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting
Show Arm Statuses
  • Teclistamab + Daratumumab + Pomalidomide: Active, Not Recruiting
  • Teclistamab + Daratumumab + Lenalidomide + Bortezomib: Active, Not Recruiting
  • Teclistamab + Nirogacestat: Active, Not Recruiting
  • Teclistamab + Lenalidomide: Active, Not Recruiting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Open and Accepting

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

Pittsburgh, PA

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Washington

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
Interested in this trial?
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