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

Not Applicable

Not yet recruiting

• Conditions: Newly Diagnosed Multiple Myeloma
• Interventions: Drug: Daratumumab

• Registration Number: NCT05088330
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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).

Study Timeline

• Study First Submitted: 2021-09-11
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Study Start: 2021-12-01
• Primary Completion: 2023-05-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-VRD	Daratumumab	treatment with D-VRD in NDMM

Primary Outcome Measures

Name	Time	Method
rate of minimal residual disease negativity	end of 8 cycles	rate of minimal residual disease negativity