A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Sinocelltech Ltd.
292 participants
Dec 29, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria7
- 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.
- Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
- Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
- Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
Interventions
Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
Pharmaceutical form: Capsules； Route of administration: Oral
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07297329