The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and/or improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.
Evidence of measurable disease.
With adequate organ function and hematological parameters.
Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.
Other hematologic malignancies.
Subjects with confirmed or suspected central nervous system infiltration or meningeal involvement.
Uncontrolled infection.
Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
Parallel
SCTC21C
DrugPharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
Bortezomib
DrugPharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
Lenalidomide
DrugPharmaceutical form: Capsules； Route of administration: Oral
Dexamethasone
DrugPharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Progression free survival (PFS)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Minimal residual disease (MRD) negativity rate for participants with CR
Proportion of participants with CR for whom MRD measurement is negative
Overall response rate (ORR)
Proportion of participants with best overall response (BOR) recorded as sCR, CR, VGPR, or partial response (PR) using the IMWG criteria
Duration of response (DOR)
Defined as the time from date of first response to date of first PD or death, whichever occurs first for participants achieving sCR, CR, VGPR, or PR
Adverse Events
Treatment-emergent adverse events/serious adverse events
PRO: EQ-5D-5L
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
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