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 that has come back after treatment, or that stopped responding to treatment — either during treatment or within 60 days of finishing it.
• People whose disease can be measured by specific blood or urine tests, with results taken within 28 days before joining the trial.
• People who have already been treated with at least three different classes of myeloma drugs: an immunomodulatory drug (such as lenalidomide or pomalidomide), a proteasome inhibitor (such as bortezomib, ixazomib, or carfilzomib), and an anti-CD38 drug (such as daratumumab or isatuximab).
• People who are at least 18 years old.
• People who are reasonably functional in daily life, as measured by a standard medical scoring system called the ECOG scale (score of 0, 1, or 2).

Who may not be able to join:

• People with active plasma cell leukaemia.
• People with a condition called amyloidosis.
• People with POEMS syndrome (a rare disorder affecting multiple body systems).
• People with a very early or low-risk form of the condition, such as monoclonal gammopathy of undetermined significance or smouldering multiple myeloma.
• People with a solitary plasmacytoma (a single tumour of plasma cells).
• People who have had a stem cell transplant within the 12 weeks before joining, or who have active graft-versus-host disease.
• People who have previously been treated with a therapy that targets a protein called BCMA.
• People whose recent blood test results fall outside the required ranges — including low white blood cell counts, low platelet counts, low haemoglobin, poor liver function, poor kidney function, or high bilirubin levels (confirm specific thresholds with the trial site).
• People who are unable to agree to specific safety monitoring requirements for the first 9 days after the first dose — this includes staying within 60 minutes' travel of the trial hospital, having a caregiver present, checking and recording their temperature every 8 hours, and being able to contact the study team within 1 hour and reach the hospital within 2 hours if a fever develops.
• People who have had certain serious heart problems in the 6 months before joining, such as a heart attack, unstable angina, uncontrolled irregular heart rhythms, blood clots, stroke, or a prolonged heart electrical interval (QTcF greater than 470 milliseconds).
• People with ongoing moderate or severe nerve problems affecting sensation or movement (Grade 2 or higher peripheral neuropathy).
• People with a history of Guillain-Barré Syndrome or similar nerve conditions, or any history of severe motor nerve disease (Grade 3 or higher).
• People who still have unresolved side effects from previous myeloma treatment that have not returned to a mild level within the past three months.
• People with active hepatitis B, hepatitis C, COVID-19, HIV, or any other active, uncontrolled infection.
• People who have had another active cancer in the past 2 years, with exceptions for certain treated skin cancers or carcinoma in situ.
• People with serious unstable medical or psychiatric conditions, or who have had major surgery within 14 days before joining.
• People with a known allergy or sensitivity to the study drug (elranatamab) or any of its ingredients.
• People who have received chemotherapy or other myeloma treatments within the past 28 days (or within 5 half-lives of the drug, whichever is shorter), or who are currently enrolled in another interventional clinical trial.
• People who have received other cancer treatments — including radiation, biological therapies, cell therapies, or high-dose steroids — within 14 days before joining.
• People who have received a live vaccine within 30 days before joining, or who are expected to need a live vaccine during the trial.
• People who are pregnant or breastfeeding, or people of childbearing potential who are unable to meet the trial's contraception requirements (confirm details with the trial site).
• People who are unable to provide signed, informed consent.

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