A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.
Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).
Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
Serum M-protein ≥ 0.5 g/dl.
Urine M-protein excretion ≥ 200 mg/24 h.
Active plasma cell leukemia (either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential).
Amyloidosis.
POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).
Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.
Single group
Elranatamab injection
DrugElranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.
Hospitalization rate
Hospitalization rate, defined as the number of patients who are hospitalized within the first 2 weeks of Cycle 1 of treatment, due to any cause, divided by the number of patients who are treated with elranatamab.
Rate of grade 3+ infections
Rate of grade 3+ infections as grade by NCI CTCAE v5 within the first 24 months of treatment, defined as the number of patients who experience a grade 3+ infection within 24 months of treatment, divided by the number of patients who are treated with elranatamab.
Overall response rate.
Overall response rate, defined by the IMWG criteria.
Progression free survival.
PFS, defined as the time from the date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurs first.
Duration of response.
DOR is defined, for participants with an overall response per IMWG criteria, as the time from the first documentation of overall response that is subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first.
Time to response.
TTR is defined, for participants with an overall response per IMWG criteria, as the time from the date of first dose to the first documentation of overall response that is subsequently confirmed.
Exploratory outcome BCMA expression (biologic tumor characteristics)
BCMA levels in blood and their relationship to clinical response and progression.
Feasibility, adherence and satisfaction of remote patient monitoring
Feasibility, adherence and satisfaction of remote patient monitoring during the first 9 days of treatment using an outpatient remote monitoring device
Patient satisfaction with the use of the remote monitoring device
Patient satisfaction with the use of the remote monitoring device will be captured using a single, 5-point likert scale question, asked when the device is returned.
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