A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3) MAJESTEC-3
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What's the purpose of this trial?

The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

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:

  • Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
  • Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Have an eastern cooperative oncology group (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 the specified range

Exclusion Criteria:

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:

    • A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present:
      • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide
      • Disease that is considered refractory to pomalidomide per IMWG,
    • A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present:
      • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib
      • Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
      • Disease that is considered refractory to bortezomib per IMWG
      • Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
 

Additional Trial Information

Phase 3

Enrollment: 560 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

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Stanford Cancer Institute

Stanford, CA

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Georgia

Grady Memorial Hospital

Atlanta, GA

Not Yet Accepting

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Not Yet Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Ascension Providence Cancer Center (Foster Winter Drive)

Southfield, MI

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Not Yet Accepting

Pennsylvania

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

Pittsburgh, PA

Not Yet Accepting

South Carolina

Medical University of South Carolina

Charleston, SC

Open and Accepting

Tennessee

Baptist Cancer Center Memphis

Mempis, TN

Not Yet Accepting

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Not Yet Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Washington

Seattle Cancer Care Alliance SCCA

Seattle, WA

Not Yet Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Not Yet Accepting
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