Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to take part (or whose legal representative has done so on their behalf)
• People who agree to allow stored tumour tissue samples from a previous biopsy to be used (exceptions may be possible with approval from the lead researcher — confirm with trial site)
• People who have a general health status rated as reasonably functional (ECOG score of 0, 1, or 2 — confirm with trial site)
• People with a life expectancy of more than 3 months
• People who have a confirmed diagnosis of multiple myeloma with measurable levels of disease, shown by specific blood, urine, or protein tests meeting set thresholds (confirm with trial site for exact measurements)
• People whose myeloma has come back or stopped responding to at least one previous treatment, which must have included both a proteasome inhibitor and an immunomodulatory drug, and for whom a stem cell transplant is not currently recommended (a delayed transplant at a later time may still be an option)
• People who have mostly recovered from side effects of previous cancer treatments, with any remaining side effects being mild to moderate (Grade 2 or lower), apart from hair loss
• People whose blood test results, taken within 30 days before starting treatment, meet the following minimum levels: white blood cell count (neutrophils), platelet count, and haemoglobin level all within acceptable ranges (confirm exact values with trial site)
• People whose liver function blood tests are within acceptable ranges, taken within 30 days before starting treatment (confirm with trial site)
• People whose kidneys are filtering at a rate of at least 30 mL/min, measured by a 24-hour urine test taken within 30 days before starting treatment
• Women who could become pregnant must have a negative pregnancy test before joining
• People of childbearing potential (men and women who have not been surgically sterilised, or women who have not been without periods for more than 1 year) must agree to use effective contraception or abstain from heterosexual activity throughout the study and for at least 4 weeks after the last dose

Who may not be able to join:

• People who have previously been treated with leflunomide
• People whose myeloma progressed during or within 60 days of receiving pomalidomide (whether alone or combined with other treatments) — prior use of pomalidomide without this type of resistance is allowed
• People who are currently using or planning to use any other myeloma treatments besides the three drugs used in this trial (leflunomide, pomalidomide, and dexamethasone)
• People who are currently receiving or planning to receive growth factor support or blood transfusions before treatment begins
• People who have previously had an allogeneic (donor) stem cell transplant
• People with a history of allergic reactions to drugs with a similar chemical make-up to the drugs used in this trial
• People who test positive for tuberculosis (TB) or latent (inactive) TB
• People who test positive for hepatitis A, B, or C
• People with a known HIV infection
• People who have previously been diagnosed with rheumatoid arthritis
• People who have had an active infection requiring treatment with medication within 2 weeks before enrolling
• People who have had a severe allergic reaction (anaphylaxis) to thalidomide, lenalidomide, pomalidomide, cholestyramine, or dexamethasone
• People who have had a non-blood cancer in the past 3 years, with some exceptions: adequately treated skin cancers, cervical carcinoma in situ, low-grade stable prostate cancer, or successfully treated early-stage breast cancer
• Women who are pregnant or breastfeeding
• People with any other health condition that the trial doctor believes would make participation unsafe
• People who, in the trial doctor's opinion, may not be able to follow all of the study procedures and requirements

Important: Always verify eligibility with the trial site directly before applying.