Phase 3 Myeloma Trial, Recruiting

Written by an AI model from the 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 are willing and able to follow the study requirements, in the opinion of the study doctor
• People who are able to understand what the study involves
• People who have given written consent to take part voluntarily, with the understanding that they may withdraw at any time
• People who have been newly diagnosed with multiple myeloma that requires treatment to start, based on specific diagnostic criteria (confirm with trial site)
• People whose myeloma can be measured through specific blood or urine protein levels that meet the minimum amounts set by the trial (confirm with trial site)
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning they are able to carry out at least some daily activities)
• People aged 65 years or younger
• People whose blood counts, liver, kidney, heart, and calcium levels meet the minimum levels required by the trial (confirm with trial site)
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or who agree to use effective contraception before, during, and for at least 28 days after the study treatment, and who agree to regular pregnancy testing during the trial
• Men who agree to use a condom during sexual activity with a woman who could become pregnant, from the time of the first dose until 6 months after the last dose, and who agree not to donate sperm during this time
• People whose side effects from any previous treatments have cleared or reduced to a mild level before joining the trial (except for hair loss)

Who may not be able to join:

• People diagnosed with certain related but different blood or plasma cell conditions, such as MGUS, smouldering myeloma, plasma cell leukaemia, primary amyloidosis, or active POEMS syndrome
• People who have had myeloma spread to the central nervous system (brain or spinal cord), or who have had certain serious blood clotting complications related to their condition
• People with a history of another cancer (other than certain skin cancers or early-stage cervical or breast cancer) unless they have been free of that cancer for 5 or more years
• People with serious medical conditions that would make participation unsafe, or conditions requiring long-term steroid or immune-suppressing medication (such as rheumatoid arthritis, lupus, or multiple sclerosis)
• Women who are pregnant or breastfeeding
• People of reproductive age who are not using effective contraception
• People currently taking part in another interventional clinical trial
• People who have taken an experimental drug within 28 days (or longer, depending on the drug) before the trial starts
• People who have had radiotherapy (other than limited pain-relief radiation) within 2 weeks of starting the trial, or who have not fully recovered from radiation side effects
• People who have had major surgery within 4 weeks before starting the trial (kyphoplasty is an exception)
• People who have nerve pain or nerve damage rated at a moderate or higher level
• People with certain heart conditions, including a heart attack within the past 6 months, uncontrolled heart rhythm problems, uncontrolled high blood pressure, or significant heart failure
• People with unstable liver or bile duct disease, such as cirrhosis, jaundice, or fluid build-up in the abdomen
• People with active kidney problems such as infection or the need for dialysis (people with protein in the urine caused by myeloma itself may still be eligible — confirm with trial site)
• People with signs of active bleeding from internal organs or mucous membranes
• People with serious mental health or medical conditions that would prevent them from understanding the consent process
• People with uncontrolled hormonal conditions such as poorly managed diabetes, or thyroid problems that have required significant medication changes or hospitalisation recently
• People with acute widespread lung disease or pericardial disease (disease around the heart)
• People with severe chronic lung disease (COPD or asthma) where lung function is significantly reduced
• People with a history of, or ongoing, interstitial lung disease
• People with a digestive condition that could affect how the study medication is absorbed
• People with an active infection requiring antibiotic, antiviral, or antifungal medication at the time treatment would begin
• People with known HIV infection
• People who test positive for Hepatitis B at screening or within 3 months before the first dose
• People who test positive for active Hepatitis C at screening or within 3 months before the first dose (people with past resolved Hepatitis C infection may still be eligible if a follow-up test is negative — confirm with trial site)
• People taking certain medications that strongly affect how the body processes drugs (CYP3A4/5 inhibitors or inducers), including within 14 days before starting the trial
• People with a known allergy or serious reaction to any of the study drugs or closely related medications (iberdomide, isatuximab, lenalidomide, or dexamethasone)

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