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 at the time of signing consent.
• People who have a confirmed diagnosis of Multiple Myeloma (MM) based on internationally recognised diagnostic standards.
• People whose general physical ability and daily functioning falls within an acceptable range as measured by a standard medical scale (ECOG score of 0, 1, or 2 — confirm with trial site if unsure what this means).
• People who have received at least 1, but no more than 2, previous treatment courses for Multiple Myeloma, and whose disease has continued to progress during or after their most recent treatment.
• People who have at least one measurable sign of the disease, based on specific laboratory test results (such as certain protein levels in the blood or urine, or abnormal light chain levels — the trial site can confirm which tests apply).
• People who have previously had an autologous stem cell transplant (using their own stem cells), provided it took place more than 100 days before the first study dose and there is no active infection present.
• People whose side effects from previous treatments have mostly resolved to a mild level or better (with hair loss being an exception).
• People whose organ function (such as kidneys, liver, and heart) meets the required laboratory standards as assessed by the trial site.
• People who are able and willing to meet the trial's strict pregnancy prevention requirements, including using highly effective contraception and undergoing pregnancy testing (applies to women who could become pregnant).
• Male participants who are willing to refrain from donating sperm and to use a condom along with an additional highly effective method of contraception during the trial if sexually active with a woman who could become pregnant.
• For the BPd treatment group specifically: people who have previously been treated with a regimen that included the drug lenalidomide, taken for at least 2 consecutive treatment cycles.

Who may not be able to join:

• People who have active plasma cell leukaemia at the time of screening.
• People who have symptomatic amyloidosis or an active condition known as POEMS syndrome.
• People who have had or currently have another type of invasive cancer (other than Multiple Myeloma), unless that cancer has been medically stable for at least 2 years or is not currently being actively treated (hormonal therapy for that other cancer may be acceptable — confirm with trial site).
• People who have a known allergic or adverse reaction to belantamab mafodotin or to any of the other study treatment components.
• People who have had plasmapheresis (a blood-filtering procedure) within 7 days before the first study dose.
• People who have previously had an allogeneic stem cell transplant (using donor stem cells).
• People who have had major surgery within 4 weeks before starting the study treatment, unless it was surgery to stabilise bones.
• People who show signs of active bleeding from the mucous membranes or internally.
• People who cannot tolerate or have medical reasons not to take antiviral preventive medication.
• People who have an active corneal (eye surface) disease, other than a mild specific condition called mild punctate keratopathy.
• People who are currently receiving other systemic anti-myeloma treatments, including chemotherapy or systemic steroids, or who have received an anti-myeloma antibody treatment within 30 days before the first study dose.
• People who have an active kidney condition (such as an active kidney infection or a need for dialysis) that could affect their safety — though people with protein in the urine caused by MM may still be considered if certain criteria are met (confirm with trial site).
• People who have previously received any treatment that targets a protein called BCMA.
• People who wear contact lenses and are not willing to stop wearing them during belantamab mafodotin treatment (bandage contact lenses may be permitted if directed by an eye care specialist).
• People living with HIV unless the infection is well-controlled, there have been no recent serious HIV-related infections, and immune cell counts are at an acceptable level.
• People with significant liver problems, including notably elevated liver enzyme or bilirubin levels, cirrhosis, or unstable liver or bile duct disease.
• People with active or unresolved Hepatitis B or C infection markers (unless the infection is confirmed as resolved by the relevant criteria).
• People with certain heart or cardiovascular risks, including untreated abnormal heart rhythms, a recent heart attack or related procedure, more severe heart failure (NYHA Class III or IV), uncontrolled high blood pressure, or a prolonged QTc interval on a heart trace (confirm with trial site if unsure what these mean).
• For the BPd group specifically: people who have previously received pomalidomide or who cannot tolerate it, or who have had a blood clot in a vein or artery within the past 3 months.
• For the BVd group specifically: people who cannot tolerate bortezomib, or whose myeloma progressed during or within 60 days of completing a bortezomib-containing treatment. Also, people who currently have moderate or severe nerve pain or nerve damage (Grade 2 or higher peripheral neuropathy).
• For the BKd group specifically: people who cannot tolerate carfilzomib, or whose myeloma progressed during or within 60 days of completing a carfilzomib-containing treatment; people with a known allergy to a substance called captisol used to prepare carfilzomib; people whose heart pumping function is below 40% as measured by an echocardiogram (heart ultrasound); people who have had fluid around the lungs requiring drainage, or fluid in the abdomen requiring drainage, within 14 days before enrolment; people who cannot tolerate adequate fluid intake due to existing lung or heart problems; or people with known pulmonary hypertension (high blood pressure in the lung arteries).

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