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
• People who are able to understand and agree to sign a consent form, or who have a legally authorised representative who can do this on their behalf
• People who have been formally diagnosed with active multiple myeloma according to recognised international diagnostic standards
• People whose myeloma can be measured and tracked using blood, urine, or imaging tests, with results confirmed within 14 days before registering for the trial (confirm with trial site for which specific measurement applies)
• People whose myeloma has come back or stopped responding to treatment, and who have already received at least 4 prior rounds of treatment, including three specific types of therapy: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody treatment
• People who are generally well enough to carry out daily activities with no or only minor limitations, as measured by a standard medical performance scale (score of 0 or 1)
• People whose blood counts meet minimum levels — including platelets, neutrophils, and haemoglobin — based on tests done within 14 days before registration, and without having received certain blood-boosting treatments very recently (confirm timing requirements with trial site)
• People whose liver and kidney function meet minimum standards based on recent blood tests (confirm specific values with trial site)
• People who previously received a type of myeloma treatment called a BCMA-targeted antibody-drug conjugate, provided any side effects from that treatment have largely resolved
• People who are willing and able to attend clinic visits and follow the study procedures throughout the trial

Who may not be able to join:

• People who have been diagnosed with plasma cell leukaemia, a condition called primary systemic light-chain amyloidosis (not related to myeloma), Waldenström macroglobulinaemia, or POEMS syndrome
• People whose myeloma has spread to the brain or the fluid surrounding the brain and spinal cord
• People with a known history of a degenerative brain or nervous system condition, a movement disorder affecting the nervous system, or who have had a seizure within the past 12 months
• People who have been taking more than a low daily dose of steroid tablets (such as prednisone) continuously within 72 hours before starting the study drug
• People who have received a live or live-attenuated vaccine within 28 days before the first dose of the study drug
• People who have previously been treated with CAR T-cell therapy or any gene therapy
• People who have had an infection serious enough to require hospitalisation or intravenous antibiotics within 2 weeks before the first dose
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection
• People with a known allergy or sensitivity to the study drug, linvoseltamab (also called REGN5458)
• Women who could become pregnant and have a positive pregnancy test
• People who are currently taking part in another clinical trial involving an experimental treatment
• Women who could become pregnant, and men, who are unwilling to use highly effective contraception from before the first dose, throughout the trial, and for at least 6 months after the last dose
• People with serious uncontrolled health conditions, including active infections, heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People who have had another cancer within the past 5 years, with some exceptions such as certain treated skin cancers or cancers that have been fully treated with curative intent (confirm with trial site)

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