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:

• People who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, based on recognised international criteria (such as a significant rise in certain protein levels in the blood or urine, or the development of new tumours or high calcium levels).
• People whose myeloma can be measured through blood or urine tests, such as a specific protein level in the blood (M-protein ≥ 0.5 g/dL), a significant amount of abnormal protein in urine over 24 hours, or abnormal levels of certain proteins called free light chains in the blood.
• People who have already received two or more previous treatment courses for myeloma, and who have been treated with (or whose disease stopped responding to) at least one drug from each of three major drug classes: an immunomodulatory drug (such as lenalidomide or pomalidomide), a proteasome inhibitor, and an anti-CD38 antibody (such as daratumumab).
• People who have never previously been treated with iberdomide or belantamab mafodotin (belamaf).
• People who have never previously received a therapy that directly targets a protein called BCMA.
• People aged 18 years or older.
• People whose general health and ability to carry out daily activities meets a certain standard, as assessed by a doctor using a recognised scale (ECOG performance status of 0, 1, or 2).
• People whose blood counts and organ function meet minimum levels set by the trial, including white blood cell counts, platelet counts, kidney function, and liver function (confirm specific values with trial site).
• People who are not pregnant and not breastfeeding, because the effects of the study drugs on an unborn child or newborn are unknown.
• People who are able to use highly effective contraception during the trial and for a set period after treatment ends — this applies to both women who could become pregnant and men (specific timeframes and methods apply; confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test before starting treatment and must agree to regular pregnancy testing throughout the trial.
• Men must agree not to donate sperm during the trial and for 6 months after the last dose.
• People who have had a previous or current separate cancer, where that cancer and its treatment are not expected to interfere with this trial's safety or results.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with certain hepatitis B results may be eligible under specific conditions, such as having undetectable virus levels and being on effective antiviral treatment (confirm with trial site).
• People who have had hepatitis C that has been successfully treated, confirmed by a negative test result after a washout period (confirm with trial site).
• People who have stored tumour tissue available to be submitted for required research testing as part of the trial.
• People who have had brain tumours that were treated and show no signs of growth on follow-up scans.

Who may not be able to join:

• People who have previously received a monoclonal antibody treatment within 2 weeks before registering for the trial.
• People who have had a severe allergic reaction (including a skin condition called erythema nodosum) to lenalidomide, pomalidomide, or similar drugs.
• People who have previously received a donor stem cell transplant (allogeneic transplant); people who had a transplant from an identical twin may be considered only if they have no history of, and no current, graft-versus-host disease.
• People who have received a live or live-attenuated vaccine within 30 days before registering.
• People who have had a blood-filtering procedure called plasmapheresis within 7 days before registering.
• People with uncontrolled HIV, hepatitis C, or hepatitis B.
• People with certain serious heart conditions, including uncontrolled abnormal heart rhythms, a heart attack or certain heart procedures within the past 3 months, severe heart failure (Class III or IV), uncontrolled high blood pressure, a hereditary heart rhythm condition, a history of certain dangerous heart rhythms, a very slow heart rate with dizziness or fainting, or poor heart pumping function (confirm details with trial site).
• People who have received certain other investigational or targeted (non-antibody) treatments within 2 weeks before registering and have not recovered from the side effects of those treatments.
• People who have had major surgery within 2 weeks before registering or have not yet recovered from surgery.
• People who are unable to swallow tablets or oral medications.
• People who have an active bacterial, viral, or fungal infection at the time of registration.
• People with significant liver disease, including cirrhosis or certain abnormal liver function results beyond defined limits (confirm with trial site).
• People with an active kidney condition (other than protein in the urine caused by the myeloma itself, which may be acceptable if other criteria are met).
• People with signs of active internal or mucosal bleeding.
• People who have had a known allergic or severe sensitivity reaction to belantamab mafodotin or chemically related drugs.
• People with active symptomatic amyloidosis, active POEMS syndrome, or active plasma cell leukaemia at the time of screening.
• People who are currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers), unless those medications can be stopped at least 14 days before starting the trial.
• People who have active corneal eye disease beyond very mild changes.
• People taking strong inhibitors of a protein called OATP alongside belantamab mafodotin.

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