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 signed and dated a consent form and are willing to follow all study procedures for the full duration of the trial
• People who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, and who have received between 1 and 3 previous rounds of treatment — including a specific type of antibody treatment targeting CD38, a proteasome inhibitor, an immunomodulatory drug, and ideally a type of cell therapy targeting BCMA (or who are not suitable for that cell therapy or have chosen to defer it)
• People aged 18 years or older
• People whose myeloma can be measured through specific blood, urine, or protein tests that meet defined thresholds
• People whose general physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale (meaning they are fully active to capable of some self-care)
• People whose blood counts meet minimum levels — including white blood cells, red blood cells, and platelets — as confirmed by recent blood tests (with some transfusion support allowed if completed at least one week before treatment starts)
• People whose kidneys are functioning at a minimum defined level, based on a standard calculation
• People whose liver function tests fall within acceptable ranges as defined by the trial
• People who are able to receive treatment as an outpatient, meaning they live within 30 minutes of the treatment site, have a reliable caregiver who can monitor them continuously for at least 48 hours after the first full treatment dose, and have not had severe reactions (grade 3–4) to similar types of treatments in the past
• People whose side effects from any previous treatment have resolved or reduced to a mild level before joining the trial
• Women of childbearing potential who have a negative pregnancy test at the screening stage
• Women who are not of childbearing potential, meaning they have gone through menopause (no periods for at least 12 consecutive months), have had their uterus and/or both ovaries surgically removed, or have medically confirmed ovarian failure
• People who agree to follow lifestyle guidelines specified by the trial throughout its duration

Who may not be able to join:

• People with certain related but distinct conditions, including smouldering multiple myeloma, IgM multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, POEMS syndrome, or plasma cell leukaemia (defined as a high level of plasma cells circulating in the blood)
• People whose myeloma has spread outside the bone marrow in a way that cannot be measured by the trial's defined methods
• People who have had another active cancer requiring treatment within the past 3 years, with the exception of certain successfully treated non-spreading skin cancers
• People whose multiple myeloma has spread to the central nervous system (brain or spinal cord)
• People with active, uncontrolled autoimmune conditions (where the immune system attacks the body)
• People with an active infection that has not been resolved or brought under control at least 14 days before joining
• People who have received radiation therapy within 2 weeks before joining (limited radiation to bone lesions may be permitted — confirm with trial site)
• People whose last systemic treatment was within 2 weeks or within 5 half-lives of the drug (whichever is shorter), with limited steroid use potentially allowed during screening under specific conditions
• People who have received radiation to multiple body sites within 2 weeks, or to a single site within 1 week
• People who have had an autologous stem cell transplant within the 100 days before joining
• People who have had an allogeneic (donor) stem cell transplant within the past year, or who have active graft-versus-host disease
• People currently taking immune-suppressing medications for other ongoing conditions
• People with other serious uncontrolled medical conditions that could put them at increased risk during the trial
• People with significant uncontrolled heart disease
• People with moderate or severe nerve damage affecting sensation or movement (grade 2 or higher peripheral neuropathy)
• People with a history of Guillain-Barré syndrome (a nervous system condition)
• People with certain surgical history, psychiatric conditions, or recent suicidal thoughts or behaviour (within the past year), or abnormal lab results that the trial doctor believes would make participation unsafe or inappropriate
• People who have taken another experimental drug within 30 days, or within 5 half-lives of that drug, before the first dose of the trial treatment (whichever period is longer)
• People who are pregnant or breastfeeding
• People with a known or suspected allergy or sensitivity to the trial treatment or any of its ingredients

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