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Completed

NCT Number: NCT07206810

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bortezomib, Lenalidomide, and Dexamethasone

Drug

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.

Primary outcomes

  1. response

    Time frame: before auto-HSCT

    sCR, CR, VGPR, PR, SD, PD

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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