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 range18 Years
SexALL
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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…