Multiple Myeloma (MM)
Conditions
Keywords
BCMA/CD3 bispecific antibody, Elranatamab
Brief summary
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.
Interventions
Anti-BCMA/CD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC).
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The subject voluntarily signs the informed consent form (ICF). 2. Aged 18-70 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria: 1. Serum M-protein ≥1.0 g/dL 2. Urine M-protein ≥200 mg/24 hours 3. Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria: （1）del(17p) with a clonal fraction \>20% and/or a TP53 mutation （2）An IGH translocation \[t(4;14), t(14;16), or t(14;20)\] combined with 1q+ or del(1p32) （3）del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion （5）β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level
Exclusion criteria
1. Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis. 2. 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. 3. Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients. 4. 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. 5. Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease (MRD) negativity rate | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events | Up to 2 year |
| Sustained MRD negativity rate | Up to 2 year |
| Overall response rate (ORR) | Up to 2 year |
| Complete response rate (CR) | Up to 2 year |
| Progression-free survival (PFS) | Up to 2 year |
| Duration of response (DoR) | Up to 2 year |
Contacts
CONTACTGang An
Outcome results
None listed