RecruitingMultiple Myeloma (MM)Multiple Myeloma RefractoryMultiple Myeloma in Relapse
A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: SCRI Development Innovations, LLC
You may qualify if…
- ✓ 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 in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- ✓ 4. For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)
You may not qualify if…
- ✕ 1. History of antitumor therapy as follows, before the first dose of study drug
- ✕ 1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.
- ✕ 2. Monoclonal antibody treatment for MM within 21 days.
- ✕ 3. Cytotoxic therapy within 21 days.
- ✕ 4. PI therapy within 14 days.
- ✕ 5. Immunomodulatory agent therapy within 7 days.
- ✕ 6. Radiotherapy within 14 days or focal radiation within 7 days.
- ✕ 7. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \[CAR\]-T cells) ≤12 weeks before the first dose of study drug
Where it's recruiting
Source: ClinicalTrials.gov · NCT07637578 · last updated 2026-08-11