A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (NCT05050097) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
United States166 participantsStarted 2021-09-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 star…
What they're measuring
1
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timeframe: Up to 1 year and 10 months
2
Number of Participants with AEs by Severity
Timeframe: Up to 1 year and 10 months
3
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Timeframe: Up to 1 year and 6 months
4
Number of Participants with Dose Limiting Toxicity (DLT)