RecruitingPhase 3NCT07297329

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


Sponsor

Sinocelltech Ltd.

Enrollment

292 participants

Start Date

Dec 29, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a new drug called SCTC21C to the standard three-drug combination (bortezomib, lenalidomide, and dexamethasone) is safe and effective for patients with newly diagnosed multiple myeloma who are not candidates for a stem cell transplant. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You are not eligible for a stem cell transplant - Your disease shows measurable signs that can be tracked - Your organ function meets required levels - You are willing to use contraception as required **You may NOT be eligible if...** - You have previously been treated for multiple myeloma - You have serious heart, liver, or kidney disease - You are pregnant or breastfeeding - You have active infections or other conditions that make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSCTC21C

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

DRUGBortezomib

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

DRUGLenalidomide

Pharmaceutical form: Capsules; Route of administration: Oral

DRUGDexamethasone

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


Locations(1)

Beijing Chaoyang Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07297329


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