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

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT04722146

Run by

Janssen Research & Development, LLC

People needed

140

Starts

2021-03-12

Expected to finish

2027-10-13

Last updated by the study team

2026-07-31

Who can join

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

You may qualify if…

• 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 1 to 3 prior lines 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); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
• Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (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 and must agree to further serum or urine pregnancy tests during the study
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment

You may not qualify if…

• Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
• Live, attenuated vaccine within 30 days before the first dose of study treatment
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College Of Wisconsin — Milwaukee, Wisconsin, United States
• St Vincents Hospital Melbourne — Fitzroy, Australia
• Alfred Health — Melbourne, Australia
• Calvary Mater Newcastle Hospital — Waratah, Australia
• UZA — Edegem, Belgium
• UZ Gent — Ghent, Belgium
• Centre Leon Berard — Lyon, France
• CHU Nantes — Nantes, France
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac, France
• Chu Rennes Hopital Pontchaillou — Rennes, France
• Institut Universitaire du cancer de Toulouse-Oncopole — Toulouse, France
• University College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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