Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma

Status Active, not recruiting

Clinical Trial Summary

This pilot trial studies how well leflunomide works for the treatment of patients with high-risk smoldering plasma cell myeloma, for the delay of disease progression. Anti-inflammatory drugs, such as leflunomide lower the body's immune response and are used with other drugs in the treatment of some types of cancer. The information learned from this study will help researchers to learn more about the anti-myeloma activity of leflunomide, and whether it may delay the onset of symptomatic multiple myeloma in patients with high-risk smoldering multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To estimate the anti-myeloma activity of leflunomide, when given as a single agent, as assessed by 6-month progression-free response rate based on International Myeloma Working Group (IMWG) criteria. 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). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 30 days, every 28 days until an alternative myeloma therapy has commenced or until disease progression, and then up to 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04370483
Study type	Interventional
Source	City of Hope Medical Center
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	October 8, 2020
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
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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
Withdrawn	`NCT03952832` - Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma	Phase 2
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.