REAL-WORLD DATA ON THE DARATUMUMAB PLUS BORTEZOMIB, THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY LENALIDOMIDE MAINTENANCE FOR TRANSPLANT-ELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

Abstract

Background: The standard approach to autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM) included induction and maintenance until progression. The newest induction protocol that had included daratumumab (dara) in combination with bortezomib, thalidomide, and dexamethasone (D-VTd) was approved in many countries worldwide. Nevertheless, only lenalidomide (lena) was approved as maintenance in the elegible setting. Real-world data (RWD) on patients from the BrazilianMultiple Myeloma Study Group (GBRAM) database platform were presented here. Aims: Present RWD on MM patients submitted to Dara-VTd induction followed by ASCT, Dara-VTd consolidation and lenalidomide as maintenance. Methods: Patients diagnosed with MM after January 1, 2018 have been included prospectively. The eligibility criteria were: intent-to-treat (ITT) MM patients submitted to Dara-VTd induction followed by ASCT, Dara-VTdconsolidation and lenalidomide as maintenance, aged over 18 years. Analysis was performed with the JAMOVI project software v2.3. Results: A total of 2,212 pts were included, 106 (4.8%) of whom were treated with the described protocol. The results presented correspond to patients submitted to the Dara-VTd protocol. The median age of the patients at diagnosis was 60 (35 - 78) years old and 60 (56.6%) patients were male. The ECOG performance was 0 for 69 (73.4%), 1 for 18 (19.1%), 2 for 4 (4.3%) and > 3 for 3 (3.2%) patients. The ISS 1, 2 and 3 scores were 37 (35.2%), 24 (22.9%) and 30 (28.6%), respectively, and those not available were 14 (13.3%). White and black race was self-declared by 62 (58.5%) and 20 (18%) of the patients, respectively. The MM IgG isotype was represented in 57 (53.8%) of the pts. The ASCT was performed in 72 (80.9%) of the patients until the present analysis. From the 17 (16%) who did not undergo the ASCT, three were bults:ecause of comorbidities, 1 case presented progression, 1 refused, 1 had another type of cancer and 2 died. The median time between the start of induction and the ASCT and begin of maintenance was 157 (115-502) and 312 (195-745) days respectively. After a median follow- up of 47.4 months, in ITT analyses, the best overall response rate (> PR) was 73.7%. Better than VGPR and > nCR were 67.9% and 29.1%, respectively. The median PFS and OS were not reached. At 36 months, we observed a PFS of 84%. Ten patients died in this period, two of them due to progression. Fiftyfour patients had started maintenance with lenalidomide. Summary/Conclusion: This study demonstrates RWD based on Dara-VTd and lenalidomide maintenance for NDMM-eligible pts. Response rates demonstrate clinical benefit, with a similar follow-up between the CASSIOPEIA trial and the present study, the PFS and OS data being similar, as well. A longer follow-up is necessary to demonstrate an advantage of lenalidomide maintenance in this setting.