Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well leflunomide works in treating patients with high-risk smoldering multiple myeloma. Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the anti-myeloma activity of leflunomide, when given as a single agent, as assessed by freedom from progression at 2-years.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of single agent leflunomide. II. To summarize and assess toxicities by type, frequency, severity, attribution, time course and duration.

III. To estimate overall and progression-free survival probabilities. IV. To estimate response rate and duration of response. V. 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.

EXPLORATORY OBJECTIVES:

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 (SMM).

IV. To evaluate the role of leflunomide in modulating the immune system. V. To examine the relationship between immunological changes and disease progression.

OUTLINE:

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 every 28 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03952832
Study type Interventional
Source City of Hope Medical Center
Contact
Status Withdrawn
Phase Phase 2
Start date December 11, 2019
Completion date June 11, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03937635 - Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma Phase 3
Active, not recruiting NCT04370483 - Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma Early Phase 1
Terminated NCT02353572 - Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Recruiting NCT05014646 - Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients Phase 2
Active, not recruiting NCT05288062 - Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma Phase 2
Recruiting NCT05136807 - Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
Recruiting NCT05312255 - Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma N/A
Active, not recruiting NCT02603887 - Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma Early Phase 1
Active, not recruiting NCT02960555 - Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR) Phase 2
Active, not recruiting NCT03631043 - Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma Early Phase 1
Recruiting NCT02726750 - Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Recruiting NCT04776395 - Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma Phase 2
Completed NCT02492750 - Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma Phase 1