Isa-Pom-Dex in Elderly/Frail Subjects With RRMM (NCT05911321) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
United States6 participantsStarted 2023-12-05
Plain-language summary
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
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 obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
. Age ≥ 18 years at the time of consent.
. Documented symptomatic multiple myeloma that has previously responded to therapy (partial response or better) and is relapsed or relapsed and refractory to the last line of therapy.
. Patients must also be refractory to at least one prior line of therapy that includes an IMiD and/or a PI, and should have received at least 2 cycles of that regimen to be evaluable for refractoriness .
. If previously treated with an anti-CD38 containing regimen, the subject must have achieved at least a PR to that line of therapy and must not have received an anti- CD38 mAb for at least 6 months prior to enrollment.
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.
1This trial is in Phase 2 and is specifically for elderly or frail patients with relapsed or refractory multiple myeloma — given my age, health status, and how many prior treatments I've had, is this combination of isatuximab, pomalidomide, and dexamethasone something worth discussing as a potential option for me?
2Since this trial is 'active but no longer recruiting,' does that mean enrollment is closed, and if so, are there other similar trials or standard treatment regimens using these same drugs that I might still be able to access?
3The trial is measuring Overall Response Rate — what does that mean in practical terms for someone in my situation, and how does that compare to the response rates I might expect from other treatment options available to me right now?
4Because the trial focuses on elderly and frail patients with co-morbidities, how would my specific health conditions and organ function affect whether this drug combination would be safe or manageable for me?
5Pomalidomide and dexamethasone are already used in multiple myeloma treatment — could I potentially receive a similar regimen outside of a clinical trial, and what would be the trade-offs between joining a study like this versus pursuing standard-of-care treatment?
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.
. Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator.
. Predicted high risk for severe toxicity from intensive regimens for RRMM, such as standard (full-dose) DPD, DVD, KPD, KRD, Ixa-PD, or Elo-PD as each regimen was published (such regimens often use, for example, twice-weekly bortezomib at 1.3 mg/m2, lenalidomide at 25 mg, or pomalidomide 4 mg). High-risk is defined as one of the following:
Exclusion criteria
. Anti-myeloma treatment within 2 weeks of cycle 1 day 1
. Prior treatment with pomalidomide
. Any monoclonal antibody therapy within the previous 30-days
. Anti-CD38 monoclonal antibody therapy within the previous 6 months
. Autologous stem cell transplantation within 12 weeks of day 1 of cycle 1
. Subjects felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status, or other severe limitations. Such limitations can be conceptualized generally as making subjects exceedingly high risk for any systemic treatment. These limitations often stem from medical comorbidities unrelated to MM and they are hence unlikely to improve with MM therapy.