Adding SCTC21C to standard bortezomib–lenalidomide–dexamethasone (VRd) for newly diagnosed multiple myeloma patients 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
This trial will test whether adding the experimental drug SCTC21C to the standard bortezomib–lenalidomide–dexamethasone (VRd) regimen helps people with newly diagnosed multiple myeloma who are not eligible for transplant live longer without disease progression and reach deeper remissions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 292 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sinocelltech Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07297329 on ClinicalTrials.gov |
What this trial studies
The study has two parts: an initial safety run-in (Part 1) followed by a randomized, controlled, open-label multicenter phase (Part 2) comparing VRd plus SCTC21C versus VRd alone. Treatment is given in 28-day cycles and continues until disease progression or unacceptable toxicity, with a screening period before treatment and a follow-up period after discontinuation. Primary efficacy endpoints include progression-free survival (PFS) and minimal residual disease (MRD) negativity rate, while safety is monitored via adverse event reporting, labs, vitals, physical exams, and ECGs. The trial also measures objective response rate (ORR) and collects standard clinical and laboratory safety data.
Who should consider this trial
Good fit: Adults with newly diagnosed multiple myeloma meeting IMWG criteria who are not eligible for autologous transplant, have measurable disease, and have adequate organ and blood function are the intended participants.
Not a fit: Patients with other active hematologic malignancies, confirmed or suspected CNS/meningeal involvement, uncontrolled infections, significant comorbid conditions, recent major surgery, or those eligible for transplant are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, adding SCTC21C could prolong progression-free survival and increase MRD negativity rates, potentially delaying disease progression and improving outcomes for patients who cannot undergo transplant.
How similar studies have performed: Adding targeted or antibody drugs to standard myeloma regimens (for example, daratumumab added to backbone therapy) has improved outcomes in transplant-ineligible patients, but SCTC21C is a novel investigational agent without established phase 3 efficacy data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Chaoyang Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.