A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (NCT04722146) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
United States140 participantsStarted 2021-03-12
Plain-language 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.
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
* 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 m…
What they're measuring
1
Number of Participants with Incidence of Adverse Events (AEs)
Timeframe: Up to 2 year and 5 months
2
Number of Participants with AEs by Severity
Timeframe: Up to 2 year and 5 months
3
Number of Participants with Abnormalities in Laboratory Values
Timeframe: Up to 2 year and 5 months
4
Number of Participants with Dose-Limiting Toxicity (DLT)
Timeframe: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)