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

Recruiting Phase 3 Interventional Study
Multiple Myeloma (MM)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
292 (estimated)
Sponsor
Sinocelltech Ltd. · Industry
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About This Trial

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.

Trial Locations
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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 …
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