Phase 3 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 have been diagnosed with high-risk "smoldering multiple myeloma" (an early, symptom-free stage of myeloma) within the last 12 months, and your condition is considered high-risk based on at least 2 specific laboratory or genetic markers (confirm with trial site).
• A bone marrow sample taken within 42 days before joining the trial shows between 10% and 59% abnormal plasma cells.
• Blood and urine protein tests taken within 28 days before joining show abnormal protein levels above certain thresholds (confirm with trial site for specific values).
• Your blood counts are at healthy enough levels — including red blood cells, platelets, and white blood cells — based on tests done within 28 days before joining.
• Your kidneys and liver are functioning well enough, based on blood tests done within 28 days before joining.
• You have no bone damage (lytic lesions), no known plasmacytoma (a tumor made of plasma cells), and no unexplained high calcium levels in your blood.
• You have no more than one small area of concern in your bone marrow seen on an MRI scan of the pelvis or spine.
• You are generally well enough to carry out daily activities (rated on a standard scale of 0–2, where 0 means fully active).
• You have been cancer-free from any previous cancer for at least 5 years (or the appropriate time for that cancer type), and it was treated with the intent to cure.
• If you have HIV, your viral load must be undetectable on a test done within the last 6 months.
• You are willing and able to follow a required safety program related to one of the study medications (lenalidomide), including pregnancy prevention requirements.
• If you have a history of blood clots (deep vein thrombosis or pulmonary embolism), you are willing to take some form of blood-thinning medication as a precaution.

Who may not be able to join:

• You have already received any treatment (chemotherapy, radiation, or steroid therapy) aimed at treating myeloma.
• You have a diagnosis of MGUS (monoclonal gammopathy of undetermined significance), which is a different, lower-risk condition.
• You have moderate or severe nerve damage (numbness, tingling, or pain in hands/feet).
• You have an active, uncontrolled infection.
• You have had a seizure in the last 6 months or have an uncontrolled seizure disorder.
• You have serious uncontrolled health conditions such as uncontrolled high blood pressure, severe heart failure, unstable chest pain, uncontrolled irregular heartbeat, or uncontrolled mental health conditions.
• You have moderate-to-severe heart failure (classified as New York Heart Association Class III or IV).
• You have a known allergy to any of the study drugs: daratumumab, lenalidomide, or dexamethasone, or to similar medications.
• You have serious lung disease — specifically, COPD with significantly reduced lung function, or moderate-to-severe persistent asthma within the past 2 years.
• You are currently pregnant or breastfeeding, as the study drugs may harm an unborn baby.
• Women who could become pregnant must agree to use two forms of birth control at the same time, starting at least 28 days before treatment and continuing for at least 28 days (or 3 months if receiving daratumumab) after the last dose.
• Men must agree to use a condom during sexual contact and avoid donating sperm for 28 days after the last dose.
• Both men and women must agree not to donate blood during the study and for at least 28 days after the last dose.
• You are currently using erythropoietin (a medication to boost red blood cell production).
• You have a pacemaker or heart device that is not compatible with MRI scans (though you may be excused from the MRI requirement — confirm with trial site).
• You are unable or unwilling to take aspirin or another blood clot prevention medication.

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