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• People who have given written consent to take part voluntarily, with the understanding that consent can be withdrawn at any time.
• People aged 18 years or older.
• People who are well enough to carry out basic daily activities (based on a standard health performance scale, scored 0–2).
• People with measurable signs of multiple myeloma in their blood, urine, or through a specific protein test, meeting at least one of several defined laboratory thresholds.
• People who have already been treated for multiple myeloma with at least one prior treatment course, including at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (drugs that target cancer cells in specific ways), and whose disease has come back or stopped responding to treatment within 60 days of finishing their last therapy.
• People with blood count results meeting minimum levels: white blood cell count (specifically neutrophils) at or above a certain threshold, platelet count at or above a certain level (without a transfusion in the past 7 days), and haemoglobin at or above 8 g/dL (red blood cell transfusions are allowed to meet this).
• People whose kidneys are working at a minimum level, as measured by a standard formula.
• People with urine protein levels below a specified threshold.
• People with liver function test results within acceptable ranges.
• People who are able to take a daily low-dose blood-thinning medication (such as aspirin, or an alternative if aspirin is not tolerated).
• People who are willing and able to follow all requirements of the Pomalyst REMS program, which is a mandatory safety program associated with one of the study drugs.
• Women who could potentially become pregnant must have a negative pregnancy test within 72 hours before starting treatment, agree to use highly effective contraception during the study and for 4 months after the last dose, and agree not to donate eggs during this period.
• Women who are not able to become pregnant may be defined by age and absence of periods for over 1 year, absence of periods for 2 or more years (with hormone testing if less than 2 years), or confirmed surgical procedures such as hysterectomy, removal of both ovaries, or tubal ligation (all requiring medical records or ultrasound confirmation).
• Men who are sexually active with a woman who could potentially become pregnant must agree to use barrier contraception (such as condoms with spermicide) for 6 months after the last dose of study drug, even if they have had a vasectomy.
• Male participants must agree not to donate sperm for 6 months after the last dose of study drug.
• People who are able to swallow capsules whole, as the pomalidomide capsules cannot be crushed, broken, or dissolved.

Who may not be able to join:

• People with current eye surface disease affecting the cornea (except very mild changes).
• People who wear contact lenses and are unwilling to stop wearing them during the study.
• People who have received myeloma treatment or an experimental drug within 2 weeks before starting the study, or who are still experiencing side effects from earlier treatment.
• People currently taking part in another clinical trial using an experimental treatment.
• People who have received an anti-CD38 antibody therapy (a specific type of targeted treatment) within the past 6 months, or any other myeloma antibody therapy within the past 30 days.
• People who have previously received any therapy targeting BCMA (a specific protein on myeloma cells).
• People who have had a plasma removal procedure (plasmapheresis) within 7 days before starting treatment.
• People whose myeloma never responded to any treatment from the very beginning (known as primary refractory disease).
• People currently taking high-dose steroid medications (low doses for non-myeloma conditions are permitted).
• People who are pregnant, breastfeeding, or planning to breastfeed.
• People with a history of another cancer within the past 3 years, unless that cancer has been fully treated and there is no evidence of disease (certain low-risk skin cancers, cervical changes, certain breast findings, and low-risk prostate findings found incidentally may still be eligible — confirm with trial site).
• People with active plasma cell leukaemia, POEMS syndrome, or primary AL amyloidosis at the time of screening (confirm with trial site if these terms are unfamiliar).
• People who test positive for HIV.
• People who test positive for active hepatitis B infection. Those with a past resolved hepatitis B infection may need additional testing; people with detectable hepatitis B virus in the blood will not be eligible. An exception applies for those with evidence of prior hepatitis B vaccination only (confirm with trial site).
• People who test positive for hepatitis C, unless the virus has been undetectable for at least 12 weeks after completing antiviral treatment.
• People with moderate or severe nerve damage in their hands or feet (peripheral neuropathy graded 2 or above) that has not improved with supportive treatment.
• People with a known serious allergic reaction to any of the study drugs (isatuximab, belantamab mafodotin, pomalidomide, or dexamethasone), such as Stevens-Johnson syndrome.
• People who received a donor stem cell transplant (allogeneic) less than 12 months ago, are still taking anti-rejection medication, or have active graft-versus-host disease.
• People who received their own stem cell transplant (autologous) less than 6 months before starting the study.
• People with a significant history of heart, neurological, hormonal, digestive, breathing, or inflammatory conditions that could make participation unsafe or interfere with results, including: severe heart failure, unstable chest pain, serious uncontrolled heart rhythm problems, a heart attack or stroke in the past 6 months, uncontrolled high blood pressure, diabetes with repeated episodes of a serious complication (ketoacidosis) in the past year, severe lung disease requiring multiple hospitalisations in the past year, unstable liver or bile duct disease, or an active bacterial, viral, or fungal infection.
• People with any other medical, mental health, or social condition that could make participation unsafe or affect the study results.
• People who have had major surgery within 4 weeks before the start of treatment.
• People who have received a live or live-attenuated vaccine within 30 days before the start of treatment.
• People who still have significant side effects from previous cancer treatment that have not returned to their normal baseline or reduced to a very mild level (with exceptions for hair loss and nerve-related side effects).

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