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

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT05083169

Run by

Janssen Research & Development, LLC

People needed

587

Starts

2021-10-14

Expected to finish

2028-09-15

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. Stable disease or 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 prior to the start of administration of study treatment
• Have clinical laboratory values within the specified range

You may not qualify if…

• 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: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) 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: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) 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, 3) Disease that is considered refractory to bortezomib per IMWG, 4) 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

Where it is running

• City of Hope — Duarte, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Henry Ford Health System — Southfield, Michigan, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baptist Cancer Center — Memphis, Tennessee, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Hospital Aleman — CABA, Argentina
• Hospital Privado Centro Medico de Cordoba — Córdoba, Argentina
• ZAS Cadix — Antwerp, Belgium
• AZ St.-Jan Brugge-Oostende AV — Bruges, Belgium
• UZ Gent — Ghent, Belgium
• Hopital de Jolimont — Haine Saint Paul La Louviere, Belgium
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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