Adding SCTC21C to standard bortezomib–lenalidomide–dexamethasone (VRd) for newly diagnosed multiple myeloma patients not eligible for transplant.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Chaoyang Hospital affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.