NCT05088330

A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

A Prospective Study of Daratumumab Combined With VRD in the Treatment of Patients With Newly Diagnosed Standard-risk Multiple Myeloma : a Single-center, Single-arm Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm study to access the effect of treatment with D-VRD in patients with newly diagnosed standard risk multiple myeloma.

Detailed description

Research object:Newly diagnosed standard-risk multiple myeloma (NDMM) diagnosed according to the International Myeloma Working Group (IMWG) standards and who have been assessed to receive Autologous Stem Cell Transplantation (ASCT) but actively refused.Objective: To explore the therapeutic options of daratumamab (D) combined with bortezomib (V), lenalidomide (R) and dexamethasone ( d) for objective assessment of patients who can receive ASCT but not to receive transplantation.Main indicators:negative rate of minimal residual disease (MRD) upon completion of cycle 8 (24 weeks).

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	treatment with D-VRD in NDMM

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-05-30
• Completion: 2024-12-31
• First posted: 2021-10-21
• Last updated: 2021-10-21