Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM (NCT04176718) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
United States44 participantsStarted 2020-05-18
Plain-language summary
This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma.
This research study involves two study drugs and two standard of care drugs.
* The names of the study drugs involved in this study are:
* Carfilzomib
* Daratumumab
* The names of the standard of care drugs involved in this study are:
* Dexamethasone
* Pomalidomide
Who can participate
Age range
18 Years – 80 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:
* Men or women ≥ 18 and ≤ 80 years old
* Diagnosis of multiple myeloma:
* Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
* ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
* Previously treated relapsed and refractory multiple myeloma
* Patients must have received at least one prior line of therapy;
* Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
* Disease progression on or within 60 days of completion of last therapy.
* ANC ≥ 1000/μL.
* G-CSF is not permitted within 14 days of screening.
* Patients with ANC \<1000/µL can be considered for screening on a case by case basis with additional monitoring, after discussion with and approval from the PI.
* Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.
* Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
* Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault equation.
* Patient has adequate hepatic function, as evidenced by each of the following:
* Serum bilirubin values \< 2 mg/dL; and
* Serum aspartate transaminase (ALT) and/or aspartate…
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 specifically for relapsed or refractory multiple myeloma — given where I am in my treatment journey, does my history of prior therapies match what this study was designed for?
2Since this is a Phase 2 trial combining four drugs — daratumumab, carfilzomib, pomalidomide, and dexamethasone — what do we know so far about serious side effects, especially since the trial is actively tracking grade 4 or higher toxicities?
3The trial is no longer enrolling new patients, but results may be available or emerging — has any data been published or presented that you could share with me to help us understand how well this four-drug combination worked?
4How does this four-drug combination compare to what standard treatment options are available to me right now, and is there a reason to wait for these trial results before deciding on my next step?
5If I were eligible for something like this combination, are there currently open trials or approved regimens using similar drugs that I could explore instead, since this one is no longer recruiting?
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
Objective response rate of the daratumumab, carfilzomib, pomalidomide, and dexamethasone combination
Timeframe: 28 Days
2
Number of dose limiting toxicity grade 4 or higher treatment related