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A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Trial Status: closed to accrual
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05050097.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationJanssen Research & Development, LLC