NCT05561049

Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens	Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2022-09-30
• Last updated: 2022-09-30

Regulatory

• FDA-regulated drug study