Actively Recruiting
A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2026-05-29
29
Participants Needed
8
Research Sites
N/A
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
Researchers are evaluating the combination of leflunomide, pomalidomide, and dexamethasone for treating relapsed or refractory multiple myeloma, a type of cancer that affects plasma cells. This phase II clinical trial aims to estimate the response rate and assess the antitumor activity of this three-drug regimen. Leflunomide may block enzymes needed for cancer cell growth, pomalidomide may modify the immune system to interfere with tumor growth, and dexamethasone is a chemotherapy drug that may stop cancer cells from growing or spreading. Participants receive leflunomide orally every day for 28 days, pomalidomide orally for the first 21 days, and dexamethasone orally on days 1, 8, 15, and 22 of each 28-day cycle. Treatment cycles repeat every 28 days as long as the disease does not progress and side effects remain acceptable. After finishing the treatment, patients are followed up 30 days later and then every three months to monitor their condition. During the study, participants will have regular evaluations to measure overall response to treatment, side effects, response duration, depth of response, clinical benefit, survival, and minimal residual disease status, all assessed up to one year. Safety will be monitored for 30 days after the last dose. The study involves oral medication and periodic follow-up visits over the course of treatment and observation periods.
CONDITIONS
Brief Title
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and assent as appropriate
- Agree to allow use of archival tumor tissue or obtain PI approval if unavailable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy greater than 3 months
- Diagnosed with multiple myeloma with measurable disease by specified protein or light chain levels
- Relapsed or refractory to at least one prior therapy including proteasome inhibitor and immunomodulatory drug, not recommended for transplant
- Recovered from prior cancer therapy toxic effects to grade 2 or less except alopecia
- Absolute neutrophil count (ANC) of 1.0 x 10^9/L or higher
- Platelet count of 75.0 x 10^9/L or higher
- Hemoglobin level of 8.0 g/dL or higher
- Total bilirubin less than or equal to 2 times upper limit of normal unless Gilbert's disease
- AST and ALT less than or equal to 3.5 times upper limit of normal
- Alkaline phosphatase less than 5 times upper limit of normal
- Creatinine clearance of 30 mL/min or higher
- Negative pregnancy test for women of childbearing potential
- Agree to use effective birth control or abstain during study and for 4 weeks after last dose
You will not qualify if you...
- Prior treatment with leflunomide
- Refractory to pomalidomide defined as progression on or within 60 days of pomalidomide use
- 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
- Allergic reactions to similar compounds as study agents
- 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 before enrollment
- History of anaphylaxis to thalidomide, lenalidomide, pomalidomide, cholestyramine, or dexamethasone
- Non-hematologic malignancies within past 3 years except certain treated cancers
- Pregnant or breastfeeding females
- Any other condition that contraindicates participation due to safety
- Inability to comply with study procedures due to feasibility or logistics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive leflunomide orally daily on days 1-28, pomalidomide orally daily on days 1-21, and dexamethasone orally on days 1, 8, 15, and 22 of each 28-day cycle. Treatment cycles repeat every 28 days until disease progression or unacceptable side effects occur.
Visits every 28 days for treatment assessment
Duration - Up to 1 year
After completing treatment, participants are followed up to monitor health and response to therapy.
1 visit 30 days after treatment and visits every 3 months thereafter
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here