A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple My… (NCT07637578) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
46 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. At least 18 years-of-age at the time of signature of the ICF
. Has documented diagnosis of MM according to IMWG diagnostic criteria
. Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
. Serum M-protein level ≥0.5 g/dL
. Urine M-protein level ≥200 mg/24 hours
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically studying whether elranatamab can be given safely as an outpatient in Cycle 1, what would happen if I had a serious reaction like cytokine release syndrome while I was at home — what monitoring or emergency plan would be in place for me?
2This is a Phase 2 trial that hasn't started recruiting yet, so how does the earlier safety data on elranatamab that already exists compare to what's standard of care for my situation right now?
3Because the main thing this study is measuring is the rate of cytokine release syndrome in the first cycle, does that mean there's still meaningful uncertainty about how safe the outpatient approach is, and how does that weigh against any potential benefit for me?
4Given that I have relapsed or refractory multiple myeloma, are there already approved treatments — including inpatient versions of elranatamab or other BCMA-targeted therapies — that my care team would recommend I try before considering enrollment in this trial once it opens?
5Since the trial isn't recruiting yet, how long might it realistically be before I could even be considered for it, and given where my disease is right now, is waiting a viable option or should we be looking at other treatments in the meantime?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Cytokine Release Syndrome (CRS) in Cycle 1
Timeframe: From Cycle 1 Day 1 to Cycle 1 Day 28 for all participants. Each cycle is 28 days.
. For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)
Exclusion criteria
. History of antitumor therapy as follows, before the first dose of study drug
. 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.
. Monoclonal antibody treatment for MM within 21 days.
. Cytotoxic therapy within 21 days.
. PI therapy within 14 days.
. Immunomodulatory agent therapy within 7 days.
. Radiotherapy within 14 days or focal radiation within 7 days.
. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \[CAR\]-T cells) ≤12 weeks before the first dose of study drug