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NCT04722146Active, not recruitingPhase 1

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

A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
140 (actual)
First submitted
20 Jan 2021
Start date
12 Mar 2021
Primary completion date
3 Oct 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04722146
EU CT number
2023-503440-14-00
EudraCT number
2020-004404-33

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 140
  • From 12 Mar 2021 to the primary completion date, 3 Oct 2025
  • 24 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincents Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Alfred Health
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Calvary Mater Newcastle Hospital
Coordinator of this site? Confirm its status
WaratahAustraliaUnknown status
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
PessacFranceCompleted
University College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
The Royal Marsden NHS Trust Sutton
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SurreyUnited KingdomUnknown status
Winship Cancer Institute, Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Levine Cancer Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
Indiana University/Melvin and Bren Simon Cancer Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Weill Cornell Medical College
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New YorkUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.