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.
This is a multi-centre, single arm, 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. Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. Study participants will receive SC administration of elranatamab until disease progression, unacceptable toxicity or death. The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long term outcome is rate of grade 3+ infections within the first 24 months of treatment. Study participants will be followed for survival for 36 months from the date of enrollment. A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.
Vancouver Cancer Center
Vancouver, British Columbia, Canada
RECRUITINGJuravinski Cancer Center
Hamilton, Ontario, Canada
RECRUITINGLondon Health Science Centre - Victoria Hospital
London, Ontario, Canada
NOT_YET_RECRUITINGHospitalization 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.
Time frame: 2 weeks
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.
Time frame: 24 months
Overall response rate.
Overall response rate, defined by the IMWG criteria.
Time frame: 36 months
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.
Time frame: 36 months
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 frame: 36 months
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.
Time frame: 36 months
Adverse Events
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Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGAEs will be graded according to NCI CTCAE Version 5. CRS and ICANS will be assessed. AEs will be characterized by type, frequency, severity, timing, seriousness, and relationship to elranatamab. AEs will be presented with and without regard to causality based on the investigator's judgment. The frequency of overall toxicity, categorized by toxicity Grades 1 through 5, will be described. Additional summaries will be provided for AEs that are observed with higher frequency and for AESIs (including CRS and ICANS).
Time frame: 36 months
Clinical laboratory data
Clinical laboratory data will be classified by grade according to NCI CTCAE version 5.0 and will be analyzed using summary statistics. The worst on-treatment grades during the treatment period will be summarized.
Time frame: 36 months.
Overall survival
OS, defined from the date of study registration to the date or death due to any cause.
Time frame: 36 months
Patient Frailty
Frailty will be measured using the IMWG frailty score and the time for the 4-meter walk test will be recorded.
Time frame: To the time of disease progression.
Frequency and Timing of Hospitalization
Frequency and timing hospitalization will be recorded during the first two weeks of the study treatment.
Time frame: 2 weeks.
Patient Quality of Life
QoL during treatment measured using the EORTC QOL Questionnaire-C30 instrument EORTC QLQ-C30
Time frame: To the time of disease progression.