Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase II trial studies how well leflunomide, pomalidomide, and dexamethasone work for the treatment of multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pomalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving leflunomide with pomalidomide and dexamethasone may work better in treating multiple myeloma compared to pomalidomide and dexamethasone alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Disqualifiers
Prior treatment with leflunomide
Patients who are pomalidomide refractory, defined as subjects who progress on or within 60 days of pomalidomide when given as a single agent or in combinatorial therapies. Prior exposure to pomalidomide without refractoriness is allowed
Current or planned use of other anti-myeloma therapies besides leflunomide, pomalidomide, and dexamethasone
Current or planned growth factor or transfusion support until after initiation of treatment
Trial design
Design model
Single group
Treatments tested in this trial
Dexamethasone
DrugGiven PO
Leflunomide
DrugGiven PO
Pomalidomide
DrugGiven PO
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Treatment (leflunomide, pomalidomide, dexamethasone)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Overall response
Clopper Pearson binomial 95% confidence intervals will be calculated.
Time frame
Up to 1 yearSecondary outcomes
1
Incidence of adverse events
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.
Time frame
Up to 30 days after last dose2
Response duration
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame
Up to 1 year3
Depth of response
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame
Up to 1 year4
Clinical benefit response
Clopper Pearson binomial 95% confidence intervals will be calculated.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov