Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03952832|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Plasma Cell Myeloma||Drug: Leflunomide Other: Quality-of-Life Assessment Other: Questionnaire Administration||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.
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.
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 every 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Leflunomide in Patients With High-Risk Smoldering Multiple Myeloma|
|Estimated Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||June 11, 2021|
|Estimated Study Completion Date :||June 11, 2021|
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.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Progression to multiple myeloma [ Time Frame: Up to 2 years ]Progression to multiple myeloma in the absence of increased calcium level, renal dysfunction, anemia, and destructive bone lesions (CRAB) features, orto symptomatic multiple myeloma that requires therapy will be assessed.
- Overall survival [ Time Frame: Up to 2 years ]Overall survival will be estimated using the product-limit method of Kaplan and Meier.
- Overall response rate (ORR) [ Time Frame: Up to 2 years ]The overall response rate and 95% Clopper Pearson binomial confidence interval (CI) will be calculated. Response rates will also be explored based on number/type of prior therapy(ies).
- Incidence of adverse events (AEs) [ Time Frame: Up to 30 days post treatment ]Adverse events will be characterized using the descriptions and grading scales found in the most recent version of Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
- Freedom from progression [ Time Frame: Up to 2 years ]Freedom from progression will be estimated using the product-limit method of Kaplan and Meier.
- Change in quality of life [ Time Frame: Baseline up to 2 years ]The quality of life questionnaire (QLQ-C30) scales (five functional scales, three symptom scales, a global health status/ quality of life (QoL) scale, and six single items) will be summarized using descriptive statistics. Changes in reported QOL over time from baseline will also be summarized.
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): NCT03952832
|United States, California|
|City of Hope Medical Center||Not yet recruiting|
|Duarte, California, United States, 91010|
|Contact: Michael A. Rosenzweig 626-256-4673 ext 62405 email@example.com|
|Principal Investigator: Michael A. Rosenzweig|
|Principal Investigator:||Michael Rosenzweig||City of Hope Medical Center|