Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma (NCT06421675) | Clinical Trial Compass
RecruitingPhase 2
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
Canada40 participantsStarted 2025-03-28
Plain-language summary
A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.
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
. Relapsed and/or refractory MM defined as:
. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).
. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:
. Serum M-protein ≥ 0.5 g/dl.
. Urine M-protein excretion ≥ 200 mg/24 h.
. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) AND an abnormal serum-free light chain ratio (\< 0.26 or \> 1.65) only for patients without measurable serum or urine M protein.
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 is a Phase 2 trial studying elranatamab as an outpatient treatment, what does that phase mean for how much is already known about its safety and effectiveness in people with my situation?
2The trial is specifically measuring hospitalization rates and serious grade 3 or higher infections — what does that tell us about the known risks of elranatamab, and how would my overall health affect my personal risk for those complications?
3Because this trial is designed around outpatient and intermittent dosing, how frequently would I need to come in for treatment and monitoring, and is that schedule realistic given my current situation and where I live?
4My myeloma is classified as relapsed or refractory — before considering this trial, are there standard approved treatments I haven't tried yet that might be worth pursuing first?
5If I were to enroll and then experience a serious infection or needed hospitalization, what would happen to my participation in the trial and what support would be available to me?
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.