Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple My… (NCT04850599) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma
United States5 participantsStarted 2022-06-14
Plain-language summary
This phase II trial studies the effect of isatuximab, carfilzomib, and pomalidomide in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Isatuximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving isatuximab, carfilzomib, and pomalidomide may help treat patients with multiple myeloma.
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:
* Participant or legally authorized representative (LAR) must provide written informed consent before any study specific procedures or interventions are performed
* Participants must be \>= 18 years of age
* Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined by 2016 International Myeloma Working Group (IMWG) criteria
* Relapsed or relapsed and refractory (R/R) MM, as defined by International Myeloma Working Group (IMWG) criteria:
* Relapsed myeloma: Previously treated myeloma that has progressed and is neither "refractory myeloma" nor "relapsed-and-refractory myeloma"
* Refractory myeloma: Nonresponsive myeloma while on primary or salvage therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as failure to achieve minimal response (MR) or better, achieved with any therapy. Cases in which there is no significant change in M protein and no evidence of clinical progression, are included, as well those cases that progress in disease course
* Primary refractory myeloma: Disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy
* Relapsed-and-refractory myeloma: Disease that is nonresponsive while on salvage therapy or progresses with 60 days of last therapy after achieving MR or better previously before progressing
* Participant has received at least 1 line of prior therapy.
* Prior exposure to proteasome inhibitor is per…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Overall response rate (ORR)
Timeframe: Up to end of cycle 4 (each cycles is 28 days), disease progression, start of new anti-myeloma therapy, or death (whichever occurs first)