Phase 2 Trial of Leflunomide in African-American and European-American Patients With High-Risk Smoldering Multiple Myeloma

Who is this study for? Patients with Smoldering Plasma Cell Myeloma
What treatments are being studied? Cholestyramine+Leflunomide
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 tuberculosis antigen (e.g. T-Spot test)

• Negative for hepatitis A, B, or C infection

• Adequate pulmonary function as defined by forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted by pulmonary function testing

• Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for three months following duration of study participation. The effects of study treatment on a developing fetus have the potential for teratogenic or abortifacient effects. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

⁃ A female of childbearing potential is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Michigan
Wayne State University/Karmanos Cancer Institute
RECRUITING
Detroit
North Carolina
Atrium Health University City/LCI-University
RECRUITING
Charlotte
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Time Frame
Start Date: 2022-03-07
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 56
Treatments
Experimental: Treatment (leflunomide)
Patients receive leflunomide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov