Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 been diagnosed with multiple myeloma, confirmed by lab testing, according to recognised diagnostic guidelines
• People whose myeloma can be measured through at least one of the following: a specific protein in the blood, abnormal light chain protein levels in the blood, protein in the urine, a high percentage of abnormal plasma cells in the bone marrow (30% or more), or a bone or tissue growth of a certain size
• People whose myeloma has at least one higher-risk feature, such as myeloma that has spread outside the bone marrow (detectable on a PET/CT scan), a high level of a specific blood protein called beta-2-microglobulin (5.5 mg/dL or above), or 50% or more abnormal plasma cells in the bone marrow
• People who have already received at least one prior treatment for multiple myeloma that included at least one drug from each of these three groups: an IMiD (such as thalidomide, lenalidomide, or pomalidomide), a proteasome inhibitor (such as bortezomib, carfilzomib, or ixazomib), and an anti-CD38 antibody treatment (such as daratumumab or isatuximab)
• People aged 18 or older
• People who are well enough to carry out basic daily activities, as assessed using a standard scale (ECOG score of 2 or less)
• People who are not pregnant and not breastfeeding — people who could become pregnant must agree to use reliable contraception during the trial and for 6 months after treatment ends
• People whose blood counts meet minimum levels: a neutrophil count of at least 1,000 cells/mm³, platelets of at least 25,000 cells/mm³, and haemoglobin of at least 8 g/dL (blood transfusion support is permitted for platelets and haemoglobin)
• People whose kidneys are functioning at a sufficient level, as measured by a standard formula (creatinine clearance of 15 mL/min or above)
• People whose liver function test results are within an acceptable range, as defined by the trial
• People with known heart disease or a history of heart-affecting treatments may still be considered, provided a clinical assessment of heart function is carried out and no specific heart conditions listed in the exclusion criteria are present (confirm with trial site)

Who may not be able to join:

• People who have previously been treated with a type of therapy known as a CD3 redirecting bispecific or trispecific antibody for multiple myeloma
• People who have plasma cell leukaemia, smouldering multiple myeloma, Waldenström's macroglobulinemia, amyloidosis, or POEMS syndrome
• People who have active involvement of the central nervous system by myeloma, or clinical signs of myeloma affecting the membranes around the brain or spinal cord
• People who have had an autologous stem cell transplant within 8 weeks before enrolling
• People who have had an allogeneic (donor) stem cell transplant within 12 weeks before enrolling, or who have active graft-versus-host disease
• People who have experienced certain serious heart-related events in the 6 months before enrolling, including heart attack, unstable angina, coronary procedures, uncontrolled heart rhythm problems, decompensated heart failure, blood clots or stroke, or a prolonged electrical interval in the heart on testing (QTcF above 470 msec)
• People with active or uncontrolled bacterial, viral (including HIV, hepatitis B, hepatitis C, or COVID-19), or fungal infections — some of these may still be considered eligible under specific conditions (confirm with trial site)
• People who have had another active cancer within the past 2 years, with the exception of certain low-risk or treated skin cancers, early-stage cancers with minimal recurrence risk, or low-risk growths that have been stable and have not required active treatment for 2 years
• People with a history of Guillain-Barré syndrome or a related condition, or a history of severe peripheral nerve and muscle problems (Grade 3 or above)
• People who have had an organ transplant and require ongoing immunosuppressive medication
• People with digestive system conditions that would affect how the body absorbs the oral medication cyclophosphamide
• People who have had major surgery within 14 days before enrolling, or who have other medical, surgical, or psychiatric conditions — including recent or active thoughts of self-harm — that could make participation unsafe or unsuitable, as judged by the trial team
• People who have had a severe allergic reaction to cyclophosphamide in the past
• People who have received a live vaccine within 4 weeks before the first dose of study treatment
• People who have received a high cumulative dose of corticosteroids (equivalent to 140 mg or more of prednisone) within the 14 days before the first dose of study treatment
• People who are unable or unwilling to follow the required infection-prevention medication schedule as outlined in the trial protocol
• People who have taken another experimental drug or vaccine within 28 days (or within 5 half-lives of that drug, whichever is shorter) before the first dose of study treatment — exceptions may be considered for people in a follow-up phase only (confirm with trial site)

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