Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) (NCT06057402) | Clinical Trial Compass
RecruitingPhase 4
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
United States, Australia, Canada80 participantsStarted 2023-10-03
Plain-language summary
This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.
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:
* Participants must agree to follow the reproductive criteria as outlined in the protocol
* Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).
Exclusion Criteria:
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
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 post-trial access study for elranatamab, does my treatment history with multiple myeloma actually make me a candidate to discuss this with you, and what would need to be true about my prior therapies for this to even be on the table?
2The study is specifically tracking serious adverse events and adverse events that cause people to stop treatment permanently — what serious side effects have already been seen with elranatamab in earlier trials that we should be weighing before considering this?
3Because this is Phase 4, elranatamab has already gone through earlier testing — does that mean there's more safety data available compared to earlier-phase trials, and how does what's known so far compare to my other current treatment options for multiple myeloma?
4This is described as a 'post-trial access' study, so what does that actually mean in practical terms — am I receiving an approved drug, a drug awaiting approval, or something else, and how does that affect my protections as a patient?
5What would it look like day-to-day to participate in this study — how often would I need to come in, how is elranatamab administered, and is that realistic given my current health and life situation?
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 nonserious adverse events (AEs) leading to permanent discontinuation
Timeframe: A minimum of 90 days after the last dose of study drug
2
Incidence of serious adverse events (SAEs)
Timeframe: A minimum of 90 days after the last dose of study drug