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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
Pharmaceutical form: Solution for infusion; Route of administration: Subcutaneous
Pharmaceutical form: Lyophilized powder for injection; Route of administration: Subcutaneous
Pharmaceutical form: Capsules; Route of administration: Oral
Pharmaceutical form: Tablets, ampoules or vials for injection; Route of administration: Oral/Intravenous
Beijing Chaoyang Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGProgression free survival (PFS)
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.
Time frame: Up to approximately 84 months after the First Participant In (FPI)
Minimal residual disease (MRD) negativity rate for participants with CR
Proportion of participants with CR for whom MRD measurement is negative
Time frame: Up to approximately 84 months after the FPI
Overall response rate (ORR)
Proportion of participants with best overall response (BOR) recorded as sCR, CR, VGPR, or partial response (PR) using the IMWG criteria
Time frame: Up to approximately 84 months after the FPI
Duration of response (DOR)
Defined as the time from date of first response to date of first PD or death, whichever occurs first for participants achieving sCR, CR, VGPR, or PR
Time frame: Up to approximately 84 months after the FPI
Adverse Events
Treatment-emergent adverse events/serious adverse events
Time frame: Up to approximately 84 months after the FPI
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