USO 23031
A Study of Outpatient Administration of Teclistamab, a BCMA-targeting Bispecific Antibody, in Multiple Myeloma Patients (64007957MMY2010)
Disease Types: Multiple Myeloma
Eligibility Requirements:
Inclusion Requirements:
- Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
- Has received 4 or more prior MM therapies including a PI, IMiD and CD38 antibody.
- Adequate organ system function
- A participant of childbearing potential must have a negative highly sensitive serum (B-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study treatment.
- A participant must be:
A: Not of childbearing potential. If a participant becomes of childbearing potential after start of the study the participant must comply with point (b) as described below.
B: Of childbearing potential and Practicing at least 1 highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study treatment and until 3 months after last dose - the end of relevant systemic exposure. Participant must agree to continue the above throughout the study and for 5 months after the last dose of study treatment.
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