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

NCT07297329 | Recruiting Phase 3 DMC

• 1 other identifier: SCTC21C-A301
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall response rate (ORR)

  Up to approximately 84 months after the FPI

• Duration of response (DOR)

  Up to approximately 84 months after the FPI

• Adverse Events

  Up to approximately 84 months after the FPI

Other Outcomes (1)

• PRO: EQ-5D-5L

  Up to approximately 84 months after the FPI

Study Arms (2)

SCTC21C + VRd (S-VRd)

EXPERIMENTAL

Drug: SCTC21C; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

VRd

ACTIVE COMPARATOR

Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

SCTC21C DRUG

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

SCTC21C + VRd (S-VRd)

Bortezomib DRUG

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

SCTC21C + VRd (S-VRd); VRd

Lenalidomide DRUG

Pharmaceutical form: Capsules； Route of administration: Oral

SCTC21C + VRd (S-VRd); VRd

Dexamethasone DRUG

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

SCTC21C + VRd (S-VRd); VRd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 22, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)