# Real-world data on the use of subcutaneous daratumumab plus bortezomib, thalidomide, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma

## TL;DR

This study examines how well a drug combination works in real-world settings for newly diagnosed multiple myeloma patients eligible for transplants.

## Contribution

The study provides real-world evidence on the effectiveness and safety of subcutaneous daratumumab plus VTd in transplant-eligible multiple myeloma patients.

## Key findings

- 91.7% of patients achieved an overall response to the treatment.
- 89.8% of patients successfully underwent autologous stem cell transplant.
- The treatment was well tolerated with safety consistent with prior knowledge.

## Abstract

Subcutaneous daratumumab in combination with bortezomib, thalidomide, and dexamethasone (D-VTd), is approved for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). However, additional real-world data are needed to assess the effectiveness and safety of D-VTd in routine clinical practice. We conducted a noninterventional, multicenter, observational study across hematology centers in Brazil to gather real-world data on D-VTd in patients with NDMM who were eligible for autologous stem cell transplant (ASCT). Eligible patients must have completed 1 or more cycle of D-VTd, on or before September 30, 2022, to be included. Data were collected retrospectively from the start of D-VTd to the study inclusion visit using patient medical records and prospectively thereafter using electronic case report forms. As of the data cutoff (August 8, 2023), 49 patients were included. By the end of consolidation, 91.7% of patients achieved an overall response (partial response or better) and 89.6% achieved very good partial response or better. Forty-five (91.8%) patients underwent stem cell mobilization with a median stem cell yield of 5.7 × 106 CD34+ cells/kg, and 44 (89.8%) patients underwent ASCT, among whom 43 out of 44 (97.7%) successfully completed ASCT. D-VTd was well tolerated, with a safety profile consistent with that previously known for daratumumab and VTd. Grade 3/4 neutropenia/febrile neutropenia and infections were reported in 32.7% and 18.4% of patients, respectively. Overall, results were consistent with the established profile of D-VTd, and these real-world effectiveness and safety results support the frontline use of subcutaneous daratumumab plus VTd in transplant-eligible patients with NDMM.

The online version contains supplementary material available at 10.1007/s00277-025-06365-3.