CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent … (NCT03798678) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
United States36 participantsStarted 2019-07-08
Plain-language summary
This phase I trial studies the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone 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 CB-839 HCl, carfilzomib, and dexamethasone may work better in treating 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:
* Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse
* Patients must have measurable disease by International Myeloma Working Group (IMWG) criteria (any of the following):
* Serum M-protein \>= 0.5 g/dL or for IgA myeloma, an elevated IgA level by quantitative IgA nephelometry
* Urine M-protein \>= 200 mg in a 24-hour collection
* Serum free light chain level \>= 10 mg/dL with an abnormal free light chain ratio
* Measurable plasmacytoma by cross sectional imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\] or \[18F\]-fluorodeoxyglucose positron emission tomography with CT \[FDG PET/CT\])
* 20% or more light chain restricted, clonal plasma cells in the bone marrow
* At least two prior lines of therapy and all patients should have at least been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,000 cells/mm3 without growth factors (within 14 days of enrollment)
* Hemoglobin \>= 8 g/dL (within 14 days of enrollment)
* Platelets \>= 50,000 cells/mm3 (\>= 30,000 cells/mm3 if bone marrow plasma cells \>= 50% at enrollment)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (seru…
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
Maximum tolerated dose (MTD) and recommended phase II dose (RP2D)