Actively Recruiting
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2026-05-04
29
Participants Needed
8
Research Sites
324 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from participant or legal representative
- Agreement to allow use of archival tumor tissue or approval from study PI if unavailable
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Life expectancy greater than 3 months
- Diagnosis of multiple myeloma with measurable disease as defined by specific protein or light chain levels
- Relapsed or refractory to at least one prior therapy including both a proteasome inhibitor and an immunomodulatory drug
- Transplant not recommended or delayed transplant acceptable
- Recovered from acute side effects of prior anti-cancer therapy to grade 2 or less (except hair loss)
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L independent of growth factor support
- Platelet count ≥ 75.0 x 10^9/L independent of transfusion support
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Total bilirubin ≤ 2 times upper limit of normal unless Gilbert's disease
- AST and ALT ≤ 3.5 times upper limit of normal
- Alkaline phosphatase less than 5 times upper limit of normal
- Creatinine clearance ≥ 30 mL/min
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and for 4 weeks after treatment
You will not qualify if you...
- Prior treatment with leflunomide
- Refractory to pomalidomide defined as progression on or within 60 days of pomalidomide
- Current or planned use of other anti-myeloma therapies besides the study drugs
- Current or planned growth factor or transfusion support before treatment start
- Prior allogeneic transplant
- History of allergic reactions to similar compounds
- Positive for tuberculosis or latent tuberculosis
- Positive for hepatitis A, B, or C
- Known HIV infection
- Prior diagnosis of rheumatoid arthritis
- Active infection requiring systemic therapy within 2 weeks prior to enrollment
- History of anaphylaxis to thalidomide, lenalidomide, pomalidomide, cholestyramine, or dexamethasone
- Non-hematologic malignancies within the past 3 years except specific treated cancers
- Pregnant or breastfeeding females
- Any condition or circumstance that the investigator believes contraindicates participation or compliance
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Seacliff
Huntington Beach, California, United States, 92648
Actively Recruiting
3
City of Hope at Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
4
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
5
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States, 92660
Actively Recruiting
6
City of Hope at South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
7
City of Hope at South Bay
Torrance, California, United States, 90503
Actively Recruiting
8
City of Hope at Upland
Upland, California, United States, 91786
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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