Who is eligible to participate?
Inclusion Criteria
– Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
– Measurable disease based on IMWG criteria as defined by at least 1 of the following:
– Serum M-protein ≥0.5 g/dL.
– Urinary M-protein excretion ≥200 mg/24 hours.
– Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
– Prior anti-multiple myeloma therapy including treatment with lenalidomide.
– ECOG performance status ≤2.
– Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
– Not pregnant and willing to use contraception.
Exclusion Criteria
– Smoldering multiple myeloma.
– Plasma cell leukemia.
– Amyloidosis.
– POEMS Syndrome.
– Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
– Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
– Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
– Previous treatment with a BCMA-directed therapy.
– Live attenuated vaccine within 4 weeks of the first dose of study intervention.
– Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Register your interest
To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au.
Study location
Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane
