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

NCT07206810 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 419

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bortezomib, Lenalidomide, and Dexamethasone

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2024-03-01
Completion
2025-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206810 on ClinicalTrials.gov