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.
I. To evaluate the anti-myeloma activity of leflunomide, when given as a single agent, as
assessed by freedom from progression at 2-years.
II. To evaluate the safety and tolerability of single agent leflunomide.
I. To summarize and assess toxicities by type, frequency, severity, attribution, time course
II. To estimate overall and progression-free survival probabilities. III. To estimate
response rate and duration of response. IV. To describe the impact of treatment on quality of
life, as assessed by the European Organization for Research and Treatment of Cancer Quality
of Life Questionnaire (EORTC QLQ-C30) Score version (v)3.0.
I. To characterize the molecular evolution of the tumor cells. II. To evaluate whether
specific genetic subtypes respond differently to leflunomide.
III. To evaluate the role of immune cells in the progression of smoldering multiple myeloma
IV. To evaluate the role of leflunomide in modulating the immune system. V. To examine the
relationship between immunological changes and disease progression.
Patients receive leflunomide orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up yearly.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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