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 multiple myeloma and have had a stem cell transplant using their own stem cells (called an autologous transplant) within one year of being diagnosed, and whose disease responded at least partially to treatment after the transplant — enrolment must happen between 60 and 100 days after the transplant
• People whose myeloma is considered high-risk, meaning it has specific genetic changes (del(17p), t(4;14), t(14;16), or t(14;20)) found on specialised testing, OR people who had a high number of abnormal plasma cells circulating in their blood at the time of diagnosis
• People who are generally able to carry out basic daily activities (a doctor will assess this using a standard scale, and a score of 0, 1, or 2 is required)
• People aged 18 years or older
• People whose blood test results, taken within 28 days before starting the trial treatment, show that their blood counts, liver function, and kidney function meet the required levels set by the trial (the trial site can confirm exact values)
• People whose urine protein levels are below a certain threshold, tested within 28 days before starting the trial treatment
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or are using a highly effective form of contraception during treatment and for at least 4 months after the last dose, and who agree not to donate eggs during this period (a negative pregnancy test is required before the first dose)
• Men who agree to use a condom during treatment and for 6 months after the last dose, and who agree not to donate sperm during this period
• People whose side effects from any previous treatment have mostly resolved (to a mild level or better) before joining, except for hair loss
• People who are able to understand the study and are willing to give written consent to take part

Who may not be able to join:

• People who have a current eye condition affecting the surface of the cornea, except for very mild changes
• People who have unstable liver or bile duct disease, such as fluid build-up in the abdomen, confusion caused by liver problems, abnormal clotting, low protein levels, swollen veins in the oesophagus or stomach, ongoing jaundice, or cirrhosis
• People who have an active kidney problem, such as a kidney infection or a need for dialysis (confirm with trial site if kidney-related symptoms are due to myeloma itself)
• People who wear contact lenses, as these cannot be worn during the trial
• People who are currently taking part in another interventional clinical trial
• People who have taken an investigational drug or any approved myeloma treatment (including steroids) within 14 days or five half-lives before the first dose, whichever is shorter
• People who have had a plasmapheresis procedure (a blood-filtering treatment) within 7 days before the first dose
• People who have received a monoclonal antibody treatment within 30 days before the first dose
• People who have had major surgery within 4 weeks before starting the trial
• People who have signs of active bleeding from internal areas or mucous membranes
• People who have significant heart problems, including uncontrolled irregular heartbeats, a certain type of serious heart conduction problem, a heart attack or related event within the past 3 months, severe heart failure (Class III or IV), or uncontrolled high blood pressure
• People who have had a known allergic or unusual reaction to belantamab mafodotin or chemically similar drugs
• People who have an active infection currently requiring treatment
• People living with HIV, unless they have been on stable HIV treatment for at least 4 weeks, their viral load is very low, their immune cell count is at an acceptable level, and they have not had a serious HIV-related infection in the past 12 months (confirm with trial site)
• People with hepatitis C, unless they have completed antiviral treatment and subsequent testing confirms the virus is no longer detectable (confirm with trial site for specific requirements)
• People with hepatitis B, unless specific conditions around viral load monitoring and antiviral treatment are met — people with cirrhosis are excluded regardless (confirm with trial site for detailed requirements; a positive hepatitis B vaccination antibody result alone does not exclude someone)
• People who have another active cancer, unless it has been medically stable for at least 2 years — people with certain treated skin cancers may be eligible without the 2-year waiting period
• People who have a serious unstable medical or psychiatric condition that could affect their safety or ability to take part in the trial
• People diagnosed with a related but different blood condition, such as smoldering myeloma, MGUS, Waldenström's macroglobulinaemia, POEMS syndrome, amyloidosis, standard-risk myeloma, or secondary plasma cell leukaemia
• People whose myeloma is high-risk but did not achieve at least a partial response after the stem cell transplant
• People who have moderate or severe nerve damage (numbness, tingling, or pain) in their hands or feet, assessed within 28 days before starting treatment
• People who are pregnant or breastfeeding
• People who, in the opinion of the treating doctor, face unacceptable risks from taking part, including because of abnormal lab results
• People who have had another cancer in the past 5 years, except for certain treated skin cancers or cervical cancer in situ
• People with a known allergy to acyclovir or similar antiviral medications
• People who cannot tolerate steroid therapy
• People who cannot take blood clot prevention medication such as aspirin, warfarin, or low-molecular-weight heparin
• People who have myeloma that has spread to the central nervous system (brain or spinal cord)
• People with a known allergy or intolerance to dexamethasone, boron-containing compounds, mannitol, or similar substances used in the trial drugs

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