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    Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    Category: Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    Daratumumab, Bortezomib, Thalidomide and Dexamethasone followed by Lenalidomide maintenance in transplant-eligible multiple myeloma patients: Overall survival comparison with the CASSIOPEIA trial.

    (PA-386) Daratumumab, Bortezomib, Thalidomide and Dexamethasone Followed by Lenalidomide Maintenance in Transplant-eligible Multiple Myeloma Patients: Overall Survival Comparison with the CASSIOPEIA Trial

    Wednesday, September 17, 2025
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    Introduction: The Dara-VTd protocol was the first daratumumab-based combination approved in our setting for transplant-eligible newly diagnosed multiple myeloma (NDMM) patients, based on the CASSIOPEIA trial. Despite its approval, the maintenance phase of the original study was not covered by official guidelines, leaving lenalidomida (Lena) as the sole maintenance option for some time. This study presents real-world data (RWD) from the Brazilian Multiple Myeloma Study Group (GBRAM) database, evaluating a novel therapeutic sequence: Dara-VTd induction followed by autologous stem cell transplantation (ASCT), Dara-VTd consolidation, and Lena maintenance. Additionally, we compared the overall survival (OS) outcomes of the GBRAM approach with those reported in the CASSIOPEIA protocol.

    Methods:

    Analyses from prospectively enrolled NDMM patients (diagnosed post-Jan/2018) and receiving Dara-VTd, followed by ASCT and Dara-VTd consolidation and Lena maintenance (GBRAM RWD cohort). Individual patient data from CASSIOPEIA were reconstructed from published Kaplan-Meier curves using the IPD from KM method and comparative analyses with RWD were conducted using R software (v4.4.1).

    Results: A total of 150 cases from 19 Brazilian centers received Dara-VTd as intent-to-treat. Median follow-up was 37 months (range 9-74). We analyzed 106 patients who completed the full protocol and maintenance follow-up. Median age at diagnosis was 58 years (37-73), with 59 (55.7%) male patients. Racial distribution showed 62 (58.5%) white patients and 44 (41.5%) non-white (mixed-race and black). ECOG performance status was 0-2 in 93 (87.7%) patients, (11.4% unavailable). The most common monoclonal isotype was IgG (49.1%), followed by IgA (25.5%) and light chain (12.2%). ISS staging distribution: I (38.7%), II (25.5%), and III (23.6%). R-ISS was unevaluable in 70 cases (66%); among evaluable cases, R-ISS 2 predominated (15.1%). CRAB features showed bone lesions in 90 patients (84.9%). OS comparison between Dara-VTd followed by lenalidomide (GBRAM cohort) versus Dara maintenance (CASSIOPEIA protocol) showed HR 0.57 (0.21 - 1.51) P=0.2. Six deaths occurred, including four from disease progression.

    Conclusions: This study analyzes real-world data from multiple myeloma (MM) patients treated with the Dara-VTd regimen followed by lenalidomide maintenance after autologous stem cell transplantation (ASCT). After a median follow-up of 37 months, a comparative analysis of overall survival (OS) between the Dara-VTd + lenalidomide maintenance approach and the original daratumumab-based regimen from the CASSIOPEIA trial showed no significant difference. However, longer follow-up is required to confirm these findings.