NCT07297329

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 \[28 days\] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and minimal residual disease (MRD) negativity rate.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
DRUG	SCTC21C	Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
DRUG	Bortezomib	Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
DRUG	Lenalidomide	Pharmaceutical form: Capsules； Route of administration: Oral
DRUG	Dexamethasone	Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-12-22
• Last updated: 2026-01-29

Locations

1 site across 1 country: China