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 are at least 18 years old (or the legal age of consent in the country where the trial is taking place) at the time of signing the consent form.
• People who have a confirmed diagnosis of Multiple Myeloma (MM) based on tissue or cell testing, and whose disease has gotten worse during or after their most recent treatment.
• People taking part in Parts 1 and 2 of the trial must have had at least 3 previous myeloma treatments, including the drugs lenalidomide, a proteasome inhibitor, and an anti-CD38 antibody treatment (given together or separately).
• People taking part in Part 3 of the trial must have had at least 1 previous myeloma treatment including lenalidomide; prior anti-CD38 treatment is not required, but no more than 70% of participants in Part 3 can be people who have never had anti-CD38 treatment (confirm with trial site).
• People who have previously had a stem cell transplant using their own cells (autologous) may be eligible, as long as the transplant was more than 100 days before the screening visit and there is no active infection at that time.
• People whose general health and ability to carry out daily activities is rated at 0, 1, or 2 on a standard medical scale (meaning fully active to capable of self-care but unable to work).
• People whose myeloma can be measured through at least one of the following: a specific protein in the blood or urine at certain levels, or abnormal levels of certain proteins in the blood called free light chains.
• People whose major organs (such as kidneys, liver, and blood system) are functioning well enough based on laboratory test results.
• People whose side effects from previous treatments have mostly resolved to mild or no symptoms, with some exceptions allowed for hair loss, nerve-related symptoms, or hormone-related conditions being managed with replacement therapy.
• People who are able to give signed consent to participate (or have a legally authorised representative who can do so).
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who are using a highly effective form of contraception (with a failure rate of less than 1% per year) during the treatment period and for 4 months after the last dose.
• Women in Part 3 who could become pregnant must follow stricter contraception rules due to the risks associated with pomalidomide, including using two forms of birth control starting at least 4 weeks before pomalidomide treatment begins, continuing through treatment and for at least 4 weeks after stopping pomalidomide, and then using one highly effective method for a further 3 months (confirm with trial site).
• All women who could become pregnant must agree not to donate eggs during the trial period.

Who may not be able to join:

• People diagnosed with certain related blood or nerve conditions, including primary AL Amyloidosis, active POEMS syndrome, or primary plasma cell leukaemia.
• People in Part 3 who have had a blood clot in a vein or artery in the past 3 months, or who are unable or unwilling to take blood clot prevention medication as required by the trial.
• People with serious unstable medical or psychiatric conditions, or significant abnormal lab results, that could affect their safety or ability to follow the trial procedures.
• People showing signs that myeloma has spread to the brain or spinal fluid.
• People with active disease affecting the surface of the eye (cornea), except for a specific mild condition called non-confluent superficial punctate keratitis.
• People with cirrhosis or unstable liver or bile duct disease, shown by symptoms such as fluid build-up in the abdomen, confusion, abnormal clotting, low protein levels, swollen blood vessels in the digestive tract, or ongoing jaundice.
• People with another active cancer diagnosis, unless they have been free of that other cancer for more than 2 years and the trial doctors determine it will not affect the evaluation of myeloma treatment. People being monitored or on hormone treatment for non-spreading prostate cancer or hormone therapy for non-spreading breast cancer are not excluded.
• People with significant untreated heart rhythm problems, or certain abnormal heart electrical readings.
• People in Parts 1 (dose escalation) and 2 only: people with a certain type of prolonged heart electrical signal (QTcF greater than 480 milliseconds), low potassium levels, or a family history of a heart rhythm condition called long QT syndrome.
• People who have had a heart attack, severe chest pain (unstable angina), or heart artery procedures (such as stenting, angioplasty, or bypass surgery) within the 3 months before screening.
• People with severe heart failure (Class III or IV on a standard medical scale).
• People with uncontrolled high blood pressure.
• People with a known serious allergic reaction to the study drug (belantamab mafodotin or its components) or to similar antibody-based treatments.
• People with an active infection currently requiring antibiotic, antiviral, or antifungal medication.
• People with a known HIV infection, unless certain specific health criteria can be met (confirm with trial site).
• People with an active kidney condition, active kidney infection, or who require dialysis. People whose only kidney issue is protein in the urine caused by the myeloma itself are not excluded.
• People who have had a blood transfusion, growth factor injections (such as G-CSF), or platelet-stimulating treatments within 2 weeks before the first dose (applies to Part 1 only).
• People in Part 1 whose myeloma stopped responding to belantamab mafodotin while on it or within 60 days of finishing it. Prior belantamab mafodotin is allowed in Part 1 if it was stopped due to side effects that later resolved.
• People in Part 2 who have previously received belantamab mafodotin.
• People in Part 3 who have previously received the study drugs (unconjugated belantamab antibody, belantamab mafodotin, or pomalidomide).
• For all parts: people who have had any prior anti-BCMA-directed treatment must have had at least a 6-month gap since their last dose before starting this trial.
• People who have had radiation therapy within 2 weeks before starting the trial.
• People who have had a plasma exchange procedure (plasmapheresis) within 7 days before the first dose.
• People who have previously had a stem cell transplant using cells from another person (allogeneic transplant).
• People who have received CAR-T cell therapy with chemotherapy-based preparation within 3 months of the screening visit.
• People who have had major surgery (other than bone-stabilising surgery) within 2 weeks of the first dose, or who have not fully recovered from surgery.
• People who have received an antibody-based treatment within 30 days before the first dose, or an investigational or approved myeloma treatment (including steroids) within 14 days or 5 half-lives before the first dose, whichever is the longer period.
• People who have received a live or live-weakened vaccine within 30 days before the first dose, or who would need one during treatment or within 70 days after the last dose.
• People with a known current problem with drug or alcohol misuse.
• People who are immediate family members of trial site staff or the trial sponsor's staff directly involved in this trial (unless a specific exception is approved by an independent review board).
• People with Hepatitis B or Hepatitis C infection, unless specific criteria can be met (confirm with trial site). In Japan, additional testing rules apply for certain Hepatitis B markers (confirm with trial site).

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