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:

• Adults aged 18 or older
• People diagnosed with high-risk smoldering multiple myeloma (SMM), defined by specific lab and bone marrow results that meet one of two sets of criteria used to identify those at higher risk of the condition progressing (confirm exact criteria with trial site)
• People whose SMM shows signs of progressing over time, such as rising protein levels in the blood, a drop in hemoglobin, worsening light chain levels, or certain genetic abnormalities found in bone marrow cells
• People who do not yet have signs of active multiple myeloma — meaning no high calcium levels, kidney problems, severe anaemia, or bone damage caused by the disease
• People with a general health status rated as fully active, restricted in strenuous activity but able to do light work, or up and about more than half of waking hours (confirm exact rating with trial site)
• People with blood test results within acceptable ranges taken within 28 days before joining, including adequate white blood cell counts, platelet counts, liver function results, and kidney function
• Women who could become pregnant and who are assigned to the lenalidomide treatment group must have negative pregnancy tests at specific times before starting treatment, and must agree to use two forms of contraception starting at least 28 days before treatment begins
• Women who could become pregnant must agree not to donate or freeze eggs during the study and for 90 days after the last dose
• Men must agree to use a condom during any sexual activity where ejaculate could pass to another person, throughout the study and for at least 90 days after the last dose — and if their female partner could become pregnant, she must also use a highly effective form of contraception
• Men who have had a vasectomy must still use a condom with spermicide, though their female partner is not required to use contraception
• Men must agree not to donate sperm during the study and for at least 90 days after the last dose
• People assigned to the lenalidomide group must be enrolled in the mandatory Revlimid REMS® safety program and follow all its requirements
• People willing and able to follow all lifestyle and safety requirements described in the study protocol
• People able to understand and sign a written informed consent form

Who may not be able to join:

• People who received treatment specifically targeting SMM within 6 months before starting the study
• People whose smoldering myeloma did not respond at least minimally to a prior lenalidomide-based treatment
• People who already have active (symptomatic) multiple myeloma, or who show signs that the disease has become active
• People who have previously received treatment for active multiple myeloma
• People currently receiving other chemotherapy, immunotherapy, radiation, or other experimental treatments (prior bisphosphonate therapy and prior radiation to a single plasmacytoma at least 6 months ago are allowed)
• People with a serious medical or psychiatric condition likely to interfere with taking part in the study
• People who have been diagnosed with or treated for another cancer within the past 2 years (some exceptions apply for certain low-risk, fully treated cancers — confirm with trial site)
• People with uncontrolled ongoing illness, such as active infection, unstable heart conditions, or severe psychiatric or social circumstances that would make it difficult to follow study requirements
• People planning to father a child during the study or within 90 days after the last dose
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after the last dose
• People known to have active HIV, hepatitis B, hepatitis C, or active COVID-19 infection (note: people who test positive for certain antibodies but have a negative PCR test may still be considered — confirm with trial site)
• People with known severe allergies or intolerances to any of the study drugs or their ingredients
• People who have recently received certain other treatments, including investigational vaccines, live vaccines, monoclonal antibody therapies, chemotherapy, or radiation, within specific timeframes before joining (confirm exact timeframes with trial site)
• People with known involvement of the disease in the central nervous system (brain or spinal fluid)
• People with a blood or bone marrow disorder called myelodysplastic syndrome, or with another active cancer currently requiring treatment (some exceptions apply — confirm with trial site)
• People who have had a stroke or seizure within 6 months before signing the consent form
• People with significant heart conditions, including severe heart failure, a recent heart attack or bypass surgery within 6 months, a history of serious heart rhythm problems, or severe heart muscle disease
• People who have had major surgery within 2 weeks before starting treatment, or who have major surgery planned during the study period (minor procedures under local anaesthetic may be allowed — confirm with trial site)
• People with uncontrolled diabetes (based on a specific blood sugar measure), active lung disease, active serious infection, a history of most autoimmune diseases, severe psychiatric conditions, dementia, or a history of not following recommended medical treatments
• People with any other condition that, in the treating doctor's judgement, would make participation unsafe or not in the person's best interest

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