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:

• You are 18 years of age or older at the time of signing the consent form
• Your body weight relative to your height (BMI) falls between 18.5 and just under 28
• You are willing to take part, understand what the study involves, and agree to sign a consent form
• You have been officially diagnosed with multiple myeloma that can be measured by tests
• Your blood protein (albumin) level is at or above a certain level (35 g/L)
• You have been newly diagnosed with multiple myeloma, have not yet received treatment, and your doctor has determined you are not suitable for high-dose chemotherapy with a stem cell transplant
• You are generally well enough to carry out light activity or normal daily tasks (confirm with trial site)
• Your blood test results during the screening period meet certain requirements, including: acceptable levels of red blood cells, white blood cells, liver function markers, kidney function, calcium levels, and platelets (the trial site will check these in detail)
• You agree to use appropriate and effective contraception during the trial and for at least 140 days after the last dose, as required by the study rules
• If you are a woman who could become pregnant, you must have a negative pregnancy blood test within 72 hours before joining the trial

Who may not be able to join:

• You have been diagnosed with a related but different blood or protein condition, such as MGUS, smoldering myeloma, primary amyloidosis, Waldenström's disease, or similar conditions
• You have a condition called plasma cell leukemia or POEMS syndrome (a rare disorder affecting multiple body systems)
• You have already received treatment for multiple myeloma (a short emergency course of steroid medication before joining may be allowed — confirm with trial site)
• You have moderate or severe nerve pain or nerve damage in your hands or feet
• You have had another type of cancer within the past 3 years (some skin cancers or cancers considered fully cured may be exceptions — confirm with trial site)
• You have signs that multiple myeloma has spread to the fluid around the brain or spinal cord
• You have been diagnosed with significant lung disease such as COPD or persistent asthma, or have had asthma within the last 2 years
• You are known to be HIV positive or to have syphilis antibodies
• You have active hepatitis B or hepatitis C infection (confirmed by specific blood and virus level tests)
• You have another serious ongoing medical or mental health condition that could interfere with the study or put you at risk
• You have significant heart problems, such as a heart attack within the last year, uncontrolled heart failure, certain irregular heart rhythms, or an abnormal heart electrical reading (ECG) above a specific level
• You have a known allergy or serious reaction to lenalidomide, steroids, monoclonal antibodies, or related medications used in this trial
• You have a history of drug or alcohol misuse in the year before joining, or are thought to be unlikely to follow the study requirements
• You are pregnant, breastfeeding, or planning to become pregnant or donate eggs during the trial or within 140 days after the last dose; or you are a man planning to father a child or donate sperm during that same period
• You have had radiation therapy within 14 days before joining the trial
• You have had a plasma exchange (plasmapheresis) procedure within 28 days before joining
• You donated blood or lost 200 mL or more of blood within the 3 months before joining
• You have had major surgery within 28 days before joining, have not fully recovered from surgery, or have surgery planned during the trial period (a minor procedure called kyphoplasty is not considered major surgery)
• You are currently taking part in another clinical trial, or have done so within the past 3 months (or longer, depending on the other study drug — confirm with trial site)
• Your doctor believes, for any reason, that joining this trial would not be in your best interest

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