NCT06682156

Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients

Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.

Detailed description

This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens. Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression. It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	carfilzomib C1: 20mg/m2，D1-2; 27mg/m2，D8-9; 36mg/m2，D15-16 C2 and subsequent cycles: 36mg/m2。

Timeline

• Start date: 2024-09-10
• Primary completion: 2028-03-31
• Completion: 2028-06-30
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China