Phase 1 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 been diagnosed with multiple myeloma (a type of blood cancer affecting plasma cells in the bone marrow), confirmed through specific bone marrow, blood, or urine test results that meet established diagnostic standards.
• People whose multiple myeloma is currently measurable through blood or urine tests showing detectable levels of abnormal proteins produced by the cancer.
• People whose multiple myeloma is currently getting worse (progressing).
• People whose multiple myeloma has come back or stopped responding to at least 2 previous treatment regimens, where those regimens included at least one drug from a class called IMIDs and one from a class called proteasome inhibitors.
• People who have previously been treated with a drug called lenalidomide, regardless of how well it worked.
• People who are not suitable candidates for a stem cell transplant.
• People who are able to understand and sign a consent form agreeing to take part in the study, and who understand they can withdraw at any time without affecting their future care.
• People who are able to attend study visits and follow the study schedule.
• People with a general health and activity level rated as reasonably functional (ECOG performance status of 0, 1, or 2 — meaning they are able to care for themselves and are up and about for more than half of waking hours at minimum) (confirm with trial site).
• People with a life expectancy of more than 3 months.
• People whose blood test results at the start of the study fall within acceptable ranges, including sufficient levels of white blood cells, platelets, and red blood cells, as well as acceptable kidney and liver function and normal potassium levels (confirm with trial site for specific values).
• People who are registered, or willing to register, in the mandatory REVLIMID REMS™ program, which is a safety monitoring program required for lenalidomide use.
• Women who could become pregnant must have a negative pregnancy test within 10–14 days before starting the study drug and again within 24 hours before the first dose, and must agree to use two forms of contraception at the same time starting at least 28 days before the study drug. They must also agree to ongoing pregnancy testing throughout the study.
• Men must agree to use a latex condom during any sexual contact with a woman who could become pregnant, even if they have had a vasectomy.
• All participants must receive counselling about pregnancy risks at least every 28 days.
• People who are able to take a low-dose aspirin daily as a blood-thinning measure (people who cannot tolerate aspirin may be eligible if they can take warfarin or a low molecular weight heparin alternative instead).

Who may not be able to join:

• People who have a condition called POEMS syndrome (a rare disorder involving nerve damage, organ enlargement, hormone problems, abnormal proteins, and skin changes).
• People who have plasma cell leukaemia (a more aggressive form of plasma cell cancer with high numbers of abnormal cells circulating in the blood).
• People who have primary amyloidosis (a condition where abnormal proteins build up in organs).
• People who have had a non-blood cancer within the past 5 years, with certain exceptions such as treated skin cancers, early-stage cervical or breast cancer, low-risk prostate cancer with stable markers, or cancers considered cured by surgery (confirm with trial site for specific exceptions).
• People with significant heart problems, including a heart attack within the past 6 months, moderate-to-severe heart failure, uncontrolled chest pain (angina), serious heart rhythm problems, disease around the heart (pericardial disease), or recent test results showing poor heart function or signs of reduced blood supply to the heart.
• People with severely high calcium levels in the blood (calcium of 12 mg/dL or above, adjusted for protein levels).
• People with a serious medical condition, significant abnormal test results, or a psychiatric illness that would prevent them from consenting to or safely participating in the study.
• People with any condition or lab abnormality that would make participation unsafe or make it hard to interpret the study results.
• People who have had major surgery within 28 days before enrolling, or who have not yet recovered from a recent major surgery (note: certain minor spinal procedures such as vertebroplasty or kyphoplasty may not be considered major surgery — confirm with trial site).
• People who are pregnant or breastfeeding.
• People who have recently received certain treatments, including: chemotherapy within 3 weeks, high-dose steroids within 3 weeks, certain immune or antibody therapies or specific cancer drugs within 21 days, lenalidomide within 7 days (or 21 days for one part of the study), extensive radiotherapy within 28 days, any other experimental drug or treatment within 28 days, or certain medications that strongly affect how the liver processes drugs within a specific washout period (confirm details with trial site).
• People who have a known allergy or sensitivity to drugs similar in composition to thalidomide, lenalidomide, or steroids.
• People who are currently using other cancer treatments at the same time.
• People who have previously developed a specific serious skin reaction called erythema nodosum (a type of rash with skin peeling) while taking thalidomide or similar drugs.
• People who are known to be HIV positive, or who have hepatitis B or C, or active tuberculosis (including latent TB or risk factors for TB becoming active).

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