About this trial
This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject voluntarily signs the informed consent form (ICF).
Aged 18-70 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Serum M-protein ≥1.0 g/dL
Disqualifiers
Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.
Peripheral neuropathy of Grade >1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization.
Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.
Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.
Trial design
Single group
Treatments tested in this trial
anti-BCMA/CD3 bispecific antibody
DrugAnti-BCMA/CD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC).
Treatment groups
Trial outcomes
Primary outcomes
Minimal residual disease (MRD) negativity rate
Secondary outcomes
Adverse events and serious adverse events
Sustained MRD negativity rate
Overall response rate (ORR)
Complete response rate (CR)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: