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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    234
  • sponsor
    Janssen Research & Development, LLC
Updated on 28 April 2022
measurable disease
lenalidomide
human chorionic gonadotropin
carfilzomib

Summary

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

Details
Condition Multiple Myeloma
Treatment Pomalidomide, Lenalidomide, Carfilzomib, Daratumumab SC, Talquetamab
Clinical Study IdentifierNCT05050097
SponsorJanssen Research & Development, LLC
Last Modified on28 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria

Live, attenuated vaccine within 4 weeks 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
History of stroke or seizure within 6 months prior to the first dose of study treatment
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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