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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Participants enrolled: 419
• From 1 Aug 2018 to the primary completion date, 1 Mar 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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