A Study of the Bortezomib, Lenalidomide, and Dexamethasone Regimen for the Treatment of Newly Diagnosed Multiple Myeloma Patients

Completed

• Conditions: Myeloma

• Registration Number: NCT07206810
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

A real-world prospective registry study for patients with newly diagnosed multiple myeloma (NDMM) has been conducted at the First Affiliated Hospital of Soochow University since August 2018. Diagnosis, staging, treatment response assessment, and risk stratification of MM were performed in accordance with the International Myeloma Working Group (IMWG) guidelines. In this study, transplant-eligible patients underwent autologous hematopoietic stem cell transplantation (auto-HSCT) after four cycles of VRD induction therapy, followed by two cycles of VRD consolidation therapy. Chemotherapy was administered in 28-day cycles as follows: subcutaneous bortezomib 1.3 mg/m² on days 1, 4, 8, and 11; oral lenalidomide 25 mg/day (or a dose-adjusted 10 mg based on renal function) from days 1 to 14; and intravenous dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12. Standard-risk patients received oral lenalidomide as maintenance therapy until disease progression. High-risk patients, defined as those with t(4;14), t(14;16), or del(17p), received bortezomib plus lenalidomide (V+R) as maintenance therapy until disease progression. Enrolled patients had complete clinical information at the time of initial diagnosis and received at least two cycles of VRD therapy. Frailty assessments were conducted prior to each chemotherapy cycle. The study protocol specified the following lenalidomide dosing based on renal function: patients with eGFR ≥60 ml/min/1.73 m² received oral lenalidomide 25 mg/day; those with 30 ml/min/1.73 m² ≤ eGFR \< 60 ml/min/1.73 m² received oral lenalidomide 10 mg/day; and those with eGFR \< 30 ml/min/1.73 m² or who were dialysis-dependent received oral lenalidomide 10 mg every other day. Long-term follow-up was performed to monitor treatment efficacy and survival status.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2024-03-01
• Study Completion: 2025-02-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

Inclusion Criteria

(1) diagnosis of active multiple myeloma according to the IMWG criteria; (2) age over 18 years; (3) newly diagnosed and treatment-naïve; (4) availability of complete clinical information; (5) receipt of at least two cycles of VRD regimen; and (6) regular follow-up at our department.

Exclusion Criteria

(1) follow-up duration of less than 6 months; (2) incomplete clinical data; and (3) failure to receive regular treatment in our department.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response	before auto-HSCT	sCR, CR, VGPR, PR, SD, PD

Trial Locations

Locations (1)

First Affiliated Hospital, Soochow University; 🇨🇳 Suzhou, Jiangsu, China