Leflunomide for Treating High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05014646

Provider View

This study is testing the effects of leflunomide, a drug that may help delay symptoms of high-risk smoldering multiple myeloma, in African-American and European-American patients.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well leflunomide works in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is a medication that can reduce the body's immune response and may help delay the onset of multiple myeloma symptoms in these patients.

Description

The main goals of this study are to see if leflunomide can prevent the progression of multiple myeloma over two years and to evaluate its safety and how well patients tolerate it. Researchers will also look at the types and severity of any side effects, how long patients live without the disease getting worse, and how the treatment affects their quality of life. Additionally, the study will explore how the tumor cells change over time, whether different genetic types of the disease respond differently to leflunomide, and how the drug affects the immune system.

Participants will take leflunomide by mouth once a day for 28 days. This cycle will repeat every 28 days as long as the disease does not progress and the side effects are manageable. After finishing the treatment, patients will have yearly follow-ups.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Age 18 or older.
  • Expected to live for more than 24 months.
  • Must be in good general health with an ECOG performance status of 0-2.
  • Identify as African-American or European-American.
  • Diagnosed with high-risk smoldering multiple myeloma, defined by having at least two of the following:
    • Bone marrow plasma cells over 20%.
    • Serum M-protein over 2 g/dL.
    • Free light chain ratio over 20.
  • Diagnosis made within the last 3 years.
  • At least 2 weeks since any prior therapy, except low-dose prednisone.
  • Platelet count of at least 50,000/uL without recent transfusions.
  • Neutrophil count of at least 1000/mm^3.
  • Liver enzymes (AST and ALT) less than 2 times the normal limit.
  • Total bilirubin less than 1.5 times the normal limit.
  • Kidney function with creatinine clearance of at least 30 mL/min.
  • Negative pregnancy test for women of childbearing potential.
  • Negative tests for tuberculosis and hepatitis A, B, or C.
  • Adequate lung function.
  • Agree to use effective contraception during and for three months after the study.

Exclusion Criteria

  • Previous treatment with leflunomide or for smoldering multiple myeloma.
  • Use of other investigational drugs or treatments during the study.
  • Evidence of organ damage due to the disease, such as high calcium levels, kidney issues, anemia, or bone lesions.
  • Certain biomarkers indicating advanced disease.
  • Previous rheumatoid arthritis diagnosis.
  • Previous allogeneic transplant.
  • Active infection requiring treatment within 2 weeks before joining.
  • Pre-existing liver disease.
  • HIV infection.
  • Allergic reactions to similar drugs.
  • Recent non-blood cancers, except for certain skin, cervical, or prostate cancers.
  • Medical conditions that may interfere with the study or consent.
  • Pregnant or breastfeeding women.
  • Any condition that may pose safety concerns or affect compliance with the study.

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