Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05014646|
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : April 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Plasma Cell Myeloma||Drug: Cholestyramine Drug: Leflunomide||Phase 2|
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 and duration.
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 (SMM).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Leflunomide in African-American and European-American Patients With High-Risk Smoldering Multiple Myeloma|
|Actual Study Start Date :||March 7, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
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.
- Progression to multiple myeloma [ Time Frame: At 2 years ]
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose ]Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.
- Overall survival [ Time Frame: From start of treatment to death, or last follow-up, whichever comes first, assessed up to 2 years ]
- Progression-free survival [ Time Frame: From randomization to progression or death or loss to follow up, whichever comes first, assessed up to 2 years ]
- Freedom-from progression [ Time Frame: From start of treatment to the first assessment showing symptomatic disease, assessed up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014646
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Michael A. Rosenzweig 626-256-4673 ext 62405 email@example.com|
|Principal Investigator: Michael A. Rosenzweig|
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute||Not yet recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Jeffrey A. Zonder 800-527-6266 firstname.lastname@example.org|
|Principal Investigator: Jeffrey A. Zonder|
|United States, North Carolina|
|Atrium Health University City/LCI-University||Not yet recruiting|
|Charlotte, North Carolina, United States, 28262|
|Contact: Saad Z. Usmani 980-442-4393 email@example.com|
|Principal Investigator: Saad Z. Usmani|
|Principal Investigator:||Michael A Rosenzweig||City of Hope Comprehensive Cancer Center|