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

Not yet recruiting

• Conditions: Newly Diagnosed Multiple Myeloma

• Registration Number: NCT05561049
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-09-30
• Study Start: 2022-10-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. newly diagnosed multiple myeloma;
2. age over 18 years, male or female;
3. glomerular filtration rate (eGFR) < 40 mL/min
4. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
5. patients who completed at least one course of treatment were included in the safety observation;
6. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria

1. acute and chronic renal insufficiency not caused by myeloma;
2. are receiving any other investigational drug or investigational medical device;
3. Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
4. patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Very good partial response (VGPR) rate	28 days after consolidation therapy