This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
\- Elranatamab will be dosed in 28-day cycles as follows: * C1D1: 12 mg SC priming dose * C1D3: 32 mg SC priming dose * C1D8, C1D15, C1D22: 76 mg SC * Cycle 2-Cycle 7: 76 mg SC on D1 and D15 * Cycle 8 and subsequent cycles: 76 mg SC on D1
FDA approved MRD testing
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGProgression-free survival (PFS)
Progression-free survival (PFS) is defined as time to progression or death.
Time frame: Through completion of follow-up (up to 5 years)
Proportion of patients achieving MRD negativity at the 10^-5 threshold per the clonoSEQ assay
Time frame: Through completion of end of study visit (up to 36 months)
Event-free survival (EFS)
Composite of progression, death, or treatment intolerance (discontinuation due to toxicity)
Time frame: Through completion of follow-up (up to 5 years)
Time to next therapy
Time to next therapy (TTNT) is defined as the time to initiation of subsequent anti-myeloma therapy (excluding standard-of-care maintenance).
Time frame: Through completion of follow-up (up to 5 years)
Maximum depth of response by IMWG criteria
Time frame: Through completion of end of study visit (up to 36 months)
Proportion of patients achieving sustained MRD-negativity at the 10^-5 threshold per the clonoSEQ assay for at least 12 months
MRD negativity per the clonoSEQ assay will be defined as less than 1 myeloma cell per 10\^6 bone marrow cells evaluated (i.e. \<10-6)
Time frame: Through completion of end of study visit (up to 36 months)
Proportion of patients discontinuing therapy per MRD-guided protocol
Time frame: Through completion of treatment (up to 36 months)
Time on treatment during study period
Time frame: Through completion of treatment (up to 36 months)
Incidence and severity of treatment-related adverse events by CTCAE v5
Time frame: From start of treatment through 90 days after completion of treatment (up to 39 months)
Overall survival (OS)
Overall survival (OS) is defined as time to death.
Time frame: Through completion of follow-up (up to 5 years)
Proportion of patients resuming therapy per MRD-guided protocol
Time frame: Through completion of treatment (up to 36 months)
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