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)
Number of Participants with Incidence of Adverse Events (AEs) — Up to 2 year and 5 months An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with AEs by Severity — Up to 2 year and 5 months Number of participants with AEs by severity will be reported.
Number of Participants with Abnormalities in Laboratory Values — Up to 2 year and 5 months Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Number of Participants with Dose-Limiting Toxicity (DLT) — Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Trial sites (27)
Facility
City
Region
Status
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
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.
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