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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma (MM)
• Intervention / Treatment: Drug: SCTC21C; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Estimated): 292
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Chaoyang Hospital Affiliated to Capital Medical University
      • Contact: yazhou_zhao; Phone Number: 010-58628288; Email: yazhou_zhao@sinocelltech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTC21C + VRd (S-VRd)	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
Active Comparator: VRd	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 84 months after the First Participant In (FPI)
Minimal residual disease (MRD) negativity rate for participants with CR	Proportion of participants with CR for whom MRD measurement is negative	Up to approximately 84 months after the FPI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 84 months after the FPI
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	Up to approximately 84 months after the FPI
Adverse Events	Treatment-emergent adverse events/serious adverse events	Up to approximately 84 months after the FPI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to approximately 84 months after the FPI

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Bortezomib; Dexamethasone
• Other Study ID Numbers: SCTC21C-A301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No