A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma (CORE-MM)
SCRI Development Innovations, LLC
Summary
This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.
Description
This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM) who have received ≥1 prior line of therapy and are double class exposed (lenalidomide and an anti-CD38). A safety-lead in will be employed for the first 6 evaluable participants (participants who have completed Cycle 1) (Cohort 1), followed by an expansion cohort (Cohort 2) of 40 participants. Eligible participants will receive a single prophylactic dose of tocilizumab follo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses 2. At least 18 years-of-age at the time of signature of the ICF 3. Has documented diagnosis of MM according to IMWG diagnostic criteria 4. Measurable disease at screening, as assessed by local laboratory, defined by any of the following: 1. Serum M-protein level ≥0.5 g/dL 2. Urine M-protein level ≥200 mg/24 hours 3. Light chain MM without measurable M-protein…