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:

• People who have been newly diagnosed with multiple myeloma that has not yet been treated, where the myeloma is causing symptoms and has been confirmed by bone marrow or tissue tests, along with at least one sign of organ or tissue damage (such as high blood calcium, reduced kidney function, low red blood cell levels, or bone damage).
• People whose myeloma shows measurable levels of abnormal protein in the blood or urine, or abnormal levels of free light chains in the blood.
• People whose myeloma is classified as the lowest-risk stage (R-ISS Stage I) based on standard staging tests.
• People whose myeloma cells show a standard (non-high-risk) gene activity pattern based on a specific genetic test called SKY92.
• People aged 18 to 70 years old at the time of signing the consent form.
• People who, in the treating doctor's opinion, are able to attend all required study visits and follow the study requirements.
• People with a general health and activity level rated at 0, 1, or 2 on the WHO performance scale (a rating of 2 is only allowed if the reduced function is caused by the myeloma itself, not by another health condition).
• People who are able to understand the study and are willing to sign a written consent form before any study procedures begin.
• People who are medically suitable to receive high-dose chemotherapy (melphalan) followed by return of their own stem cells.
• People who have suitable veins or vascular access to allow blood cell collection (leukapheresis).
• Male participants who agree to use contraception during the treatment period and for at least 5 months after the last dose of isatuximab, and who agree not to donate sperm during this time.
• Female participants who are not pregnant and not breastfeeding, and who either are not of childbearing potential, or who meet the required pregnancy testing schedule and agree to use highly effective contraception throughout the study and for at least 5 months after the last dose of isatuximab or lenalidomide (confirm specific contraception and testing requirements with the trial site).
• All participants who agree not to donate blood during treatment and for at least 5 months after the last dose of lenalidomide or isatuximab, and who agree never to share lenalidomide with another person.

Who may not be able to join:

• People with a type of anaemia where the immune system destroys red blood cells (confirmed by a positive direct Coombs test).
• People whose myeloma has spread to the brain or spinal cord (central nervous system).
• People with a significant history or current condition affecting the brain or nervous system, such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis.
• People with a current or past diagnosis of plasma cell leukaemia, Waldenström's macroglobulinemia, POEMS syndrome, or significant amyloidosis.
• People with a form of myeloma that does not produce measurable abnormal proteins (non-secretory myeloma).
• People with amyloidosis affecting organs outside the bone marrow (systemic AL amyloidosis).
• People who have received chemotherapy or radiation therapy in the past 5 years, with limited exceptions for local radiotherapy or low-dose emergency steroid treatment (confirm with trial site if previous treatment for smouldering myeloma or a single dose of bortezomib was received).
• People whose blood test results fall outside acceptable ranges, including: too few white blood cells, too few platelets, poor kidney filtering function, abnormal liver enzyme or bilirubin levels, or abnormal blood clotting results — or people who require ongoing blood-thinning medication (confirm specific thresholds with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is below 45% on an echocardiogram (heart ultrasound).
• People whose blood oxygen level is below 92% while breathing normal room air.
• People known to be HIV positive or to have an active hepatitis A, B, or C infection (some people with prior hepatitis B or C exposure and no active infection may still be eligible — confirm with trial site).
• People who have had another cancer in the past 5 years (other than multiple myeloma).
• People with severe nerve pain affecting daily life (severe painful polyneuropathy).
• People with a known allergy or hypersensitivity to any of the study drugs.
• People with any medical reason that would prevent them from safely taking any of the study drugs.
• People who are in prison, legally detained, or unable or unwilling to follow the study schedule and requirements.
• People currently participating in another interventional clinical trial, or who have done so within the 4 weeks before joining this trial (exceptions may apply at the investigator's discretion).
• People with an active serious infection currently requiring intravenous antibiotic treatment.
• People with any serious uncontrolled medical condition that, in the treating doctor's opinion, could put them at excessive risk or interfere with the study results.
• People with a known hypersensitivity to certain inactive ingredients used in the study medications, where this cannot be managed with standard pre-treatment (confirm specific ingredients with trial site).

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