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

NCT ID: NCT07297329

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCTC21C + VRd (S-VRd)

Group Type: EXPERIMENTAL

SCTC21C

Intervention Type: DRUG

Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous

Bortezomib

Intervention Type: DRUG

Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous

Lenalidomide

Intervention Type: DRUG

Pharmaceutical form: Capsules； Route of administration: Oral

Dexamethasone

Intervention Type: DRUG

Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

VRd

Group Type: ACTIVE_COMPARATOR

Bortezomib

Intervention Type: DRUG

Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous

Lenalidomide

Intervention Type: DRUG

Pharmaceutical form: Capsules； Route of administration: Oral

Dexamethasone

Intervention Type: DRUG

Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Interventions

SCTC21C

Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous

Intervention Type: DRUG

Bortezomib

Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous

Intervention Type: DRUG

Lenalidomide

Pharmaceutical form: Capsules； Route of administration: Oral

Intervention Type: DRUG

Dexamethasone

Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SCTC21C-A301

Identifier Type: -

Identifier Source: org_study_id