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Recruiting NCT07297329

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

Phase III Interventional Multiple Myeloma (MM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCTC21C, Bortezomib, Lenalidomide, Dexamethasone.
Who it may be relevant to
Registry conditions: Multiple Myeloma (MM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Progression free survival (PFS) [Time frame: Up to approximately 84 months after the First Participant In (FPI)]
  • Minimal residual disease (MRD) negativity rate for participants with CR [Time frame: Up to approximately 84 months after the FPI]
Secondary outcome measures (3)
  • Overall response rate (ORR) [Time frame: Up to approximately 84 months after the FPI]
  • Duration of response (DOR) [Time frame: Up to approximately 84 months after the FPI]
  • Adverse Events [Time frame: Up to approximately 84 months after the FPI]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Chaoyang Hospital affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT07297329 · SCTC21C-A301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗