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 aged 18 or older.
• People whose general health and ability to carry out daily activities meets a certain level of functioning (rated 0 or 1 on a standard oncology scale — confirm with trial site).
• People with multiple myeloma (MM) that has come back or stopped responding to treatment, who have already received at least 2 previous treatment courses for MM, including specific drug types known as PIs and IMiDs.
• People whose MM can be measured through specific blood or urine tests showing certain levels of abnormal proteins.
• People who agree to use contraception during the trial (applies to those who could father or carry a child).
• Substudy 01 and 06: People who have never received a type of drug that targets CD38, or who have received it but finished that treatment at least 12 months ago (and received at least 2 cycles of it).
• Substudies 02 and 03: People who have never received a CD38-targeting drug, or who have received it but whose myeloma did not progress within 60 days of the last dose, and who finished that treatment at least 6 months ago.
• Substudy 04: People who have previously received both a CD38-targeting drug and, if available in their region, a BCMA-targeting drug (at least 2 cycles of each).
• Substudy 05: People who have received at least 2 cycles of a CD38-targeting drug, and — for people in regions where a BCMA-targeting treatment is approved and covered — at least 2 cycles of a BCMA-targeting drug are also required.

Who may not be able to join:

• People with certain related blood or plasma cell conditions, including primary systemic amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
• People with an infection that is not under control within 14 days before starting the trial.
• People who have had a significant heart or blood vessel problem in the 3 months before starting the trial, such as a heart attack, stroke, heart failure, blood clot, or serious heart rhythm problem.
• People with HIV requiring antiviral treatment, or with active hepatitis A.
• People with an uncontrolled or active hepatitis B infection.
• People with an active hepatitis C infection.
• People who have had certain stomach or digestive conditions (such as treatment-resistant ulcers, severe inflammation of the stomach or oesophagus, or inflammatory bowel disease) in the 3 months before starting the trial.
• People with a second cancer (other than certain treated skin cancers) unless it was successfully treated with curative intent more than 3 years before starting the trial.
• People who have received any MM treatment, including steroids such as dexamethasone, within 14 days before starting the trial.
• People who have a known reason they cannot receive the study treatment.
• People who have received a live vaccine within 4 weeks before starting the trial (note: standard flu and COVID-19 vaccines that do not contain live virus are generally permitted — confirm with trial site).
• People whose blood test results fall below or above certain levels, including low red blood cells, low platelets, low white blood cells, reduced kidney function, or abnormal liver readings.
• People with severely high calcium levels in the blood (grade 3 or 4 — confirm with trial site).
• Substudy 01 only: People with a condition that significantly affects how the body absorbs medication taken by mouth.
• Substudy 02 only: People with a history of certain treated skin or cervical cancers, even if considered cured; people taking blood-thinning or anti-clotting medications at therapeutic doses within 7 days before the first dose; or people with certain abnormal blood clotting test results.
• Substudy 03 only: People with a current eye surface condition (except mild punctate keratopathy — confirm with trial site); or people who have previously received a drug called belantamab mafodotin.
• Substudy 04 only: People with MM that has spread to the brain or spinal fluid; people with a history of seizures; people currently taking certain medications that are processed by the liver and have a narrow safe dosing range (if close monitoring is not possible); people with an active autoimmune disease that has required systemic treatment in the past 2 years; or people who have had a certain type of stem cell transplant using donor cells (allogeneic transplant).
• Substudy 05 only: People who are unable to swallow tablets.
• Substudy 06 only: People with a history of active autoimmune disorders; a history of certain immune-related blood conditions; active graft-versus-host disease or ongoing treatment to suppress it; prior donor stem cell transplant; active Epstein-Barr virus (EBV) infection; a known history of a rare immune condition called HLH; haemoglobin below a specific level (9 g/dL); or prior treatment with certain specific drug types targeting CD47 or a related protein.

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