Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04508790|
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Drug: Dexamethasone Drug: Leflunomide Drug: Pomalidomide||Phase 2|
I. To estimate the response rate and to evaluate the antitumor activity of the three-drug combination, leflunomide, pomalidomide, and dexamethasone, in patients with relapsed/refractory multiple myeloma.
I. To characterize and evaluate toxicities, including type, frequency, severity, attribution, time course, and duration.
II. To obtain estimates of response duration, depth of response, clinical benefit, and survival (overall and progression-free).
Patients receive leflunomide orally (PO) on days 1-28, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||November 27, 2020|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Treatment (leflunomide, pomalidomide, dexamethasone)
Patients receive leflunomide PO on days 1-28, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall response [ Time Frame: Up to 1 year ]Clopper Pearson binomial 95% confidence intervals will be calculated.
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose ]Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
- Response duration [ Time Frame: Up to 1 year ]Will be estimated using the product-limit method of Kaplan and Meier.
- Depth of response [ Time Frame: Up to 1 year ]Will be estimated using the product-limit method of Kaplan and Meier.
- Clinical benefit response [ Time Frame: Up to 1 year ]Clopper Pearson binomial 95% confidence intervals will be calculated.
- Overall survival [ Time Frame: Up to 1 year ]Will be estimated using the product-limit method of Kaplan and Meier.
- Minimal residual disease (MRD) status [ Time Frame: Up to 1 year ]A patient will be considered as having minimal residual diseases if a positive result is obtained using the Adaptive MRD testing. MRD testing will be performed at Adaptive Biotechnologies.
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): NCT04508790
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Michael A. Rosenzweig 626-256-4973 ext 62405 email@example.com|
|Principal Investigator: Michael A. Rosenzweig|
|Principal Investigator:||Michael A Rosenzweig||City of Hope Medical Center|