A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
NCT ID: NCT04722146
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2021-03-12
2027-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
Teclistamab
Participants will receive teclistamab.
Daratumumab
Participants will receive daratumumab.
Pomalidomide
Participants will receive pomalidomide.
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
Teclistamab
Participants will receive teclistamab.
Daratumumab
Participants will receive daratumumab.
Lenalidomide
Participants will receive lenalidomide.
Bortezomib
Participants will receive bortezomib.
Treatment Regimen C: Teclistamab + Nirogacestat
Participants will receive teclistamab plus nirogacestat.
Teclistamab
Participants will receive teclistamab.
Nirogacestat
Participants will receive nirogacestat.
Treatment Regimen D: Teclistamab + Lenalidomide
Participants will receive teclistamab plus lenalidomide.
Teclistamab
Participants will receive teclistamab.
Lenalidomide
Participants will receive lenalidomide.
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Participants will receive teclistamab plus daratumumab plus lenalidomide.
Teclistamab
Participants will receive teclistamab.
Daratumumab
Participants will receive daratumumab.
Lenalidomide
Participants will receive lenalidomide.
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
Teclistamab
Participants will receive teclistamab.
Daratumumab
Participants will receive daratumumab.
Lenalidomide
Participants will receive lenalidomide.
Bortezomib
Participants will receive bortezomib.
Interventions
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Teclistamab
Participants will receive teclistamab.
Daratumumab
Participants will receive daratumumab.
Pomalidomide
Participants will receive pomalidomide.
Lenalidomide
Participants will receive lenalidomide.
Bortezomib
Participants will receive bortezomib.
Nirogacestat
Participants will receive nirogacestat.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research and Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research and Development LLC
Locations
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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
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
Seattle Cancer Care Alliance
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
The Christie Nhs Foundation Trust
Manchester, , United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey, , United Kingdom
Countries
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Other Identifiers
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64007957MMY1004
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004404-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503440-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108927
Identifier Type: -
Identifier Source: org_study_id