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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2022
  • participants needed
    60
  • sponsor
    Janssen Research & Development, LLC
Updated on 26 June 2021
measurable disease
lenalidomide
human chorionic gonadotropin
bortezomib
refractory multiple myeloma

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Pomalidomide, Lenalidomide, Bortezomib, Daratumumab, Nirogacestat, Teclistamab
Clinical Study IdentifierNCT04722146
SponsorJanssen Research & Development, LLC
Last Modified on26 June 2021

Eligibility

Yes No Not Sure

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 at least 1 prior line 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)
Have measurable disease at screening as defined by at least one of the following: serum M-protein level greater than or equal to (>=) 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligram (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
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment

Exclusion Criteria

Prior treatment with any therapy that targets B-cell maturation antigen (BCMA)
Live, attenuated vaccine within 4 weeks before the first dose of study treatment, unless approved by sponsor
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
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