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Clinical Trials in the UK / NCT04722146
Active, not recruiting Phase 1

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

NCT04722146 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2021-03-12
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

TeclistamabDaratumumabPomalidomideLenalidomideBortezomibNirogacestat

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of California San Francisco San Francisco California
Colorado Blood Cancer Institute Denver Colorado
Winship Cancer Institute Emory University Atlanta Georgia
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
Washington University School Of Medicine St Louis Missouri
Hackensack University Medical Center Hackensack New Jersey
Memorial Sloan-Kettering Cancer Center New York New York
Weill Cornell Medical College New York New York
Levine Cancer Institute Charlotte North Carolina
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Tennessee Oncology Nashville Tennessee
Fred Hutchinson Cancer Center Seattle Washington
Medical College Of Wisconsin Milwaukee Wisconsin
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

On this site

📄 Darzalex (daratumumab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Janssen Research & Development, LLC trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04722146 on ClinicalTrials.gov ↗ ← All trials in the UK