Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and Eu… (NCT05014646) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients
United States27 participantsStarted 2022-03-07
Plain-language summary
This phase II trial studies the effects of leflunomide in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma in patients of African-American and European decent.
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:
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* Patients must be age \>= 18 years
* Patients must have a life expectancy of \> 24 months
* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must identify as African-American OR European-American
* Patients must have a diagnosis of high risk smoldering multiple myeloma, as defined below:
* The presence of \>= 2 of the following risk factors:
* Bone marrow plasma cell percentage (BMPC%) \> 20%
* Serum M-protein \> 2 g/dL
* Free light chain ratio (FLCr) \> 20
* A diagnosis of high-risk SMM must have been made within the last 3 years
* At least 2 weeks from prior therapy to time of start of treatment. Prior therapy includes steroids (except prednisone or equivalent - up to 10 mg per day is allowed)
* Platelet count \>= 50,000/uL. Platelet transfusions are not allowed within 14 days of platelet assessment
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.0 x upper limit of normal (ULN)
* Total bilirubin \< 1.5 x ULN
* Calculated creatinine clearance (CrCl) \>= 30 mL/min per 24-hour urine collection or the Cockcroft-Gault formula
* Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only), to be performed locally within the screening period
* Negative for…
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.