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

Condition(s) studied

Investigational drug(s) / intervention(s)

SCTC21C: Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous

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

Lenalidomide: Pharmaceutical form: Capsules； Route of administration: Oral

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

Study 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

Primary outcome measure(s)

• Progression free survival (PFS) — Up to approximately 84 months after the First Participant In (FPI)
  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.
• Minimal residual disease (MRD) negativity rate for participants with CR — Up to approximately 84 months after the FPI
  Proportion of participants with CR for whom MRD measurement is negative

Trial sites (1)

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