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Quadruplet Therapy with Isatuximab for Newly Diagnosed Multiple Myeloma
Combining bortezomib, lenalidomide, and dexamethasone (VRd) is a well-established frontline therapy for treating multiple myeloma. Investigators now report a long-term follow-up of a phase 3, industry-sponsored, multicenter trial that randomized 446 transplant-ineligible patients with multiple myeloma to VRd plus isatuximab (isa-VRd) or VRd alone.
Patients (age range, 18–80) had previously untreated disease and were ineligible for transplantation due to age over 65 or significant comorbidities. Four 6-week induction cycles in each study arm were followed by continuous 4-week maintenance cycles of isa-Rd or Rd. For 25 patients receiving Rd whose disease progressed, crossover to isa-Rd was permitted. The median follow-up was 59.7 months.
The 60-month progression-free survival was significantly greater with isa-VRd than VRd alone (63.2% vs. 45.2%; hazard ratio, 0.60). Achievement of complete remission was significantly greater with isa-VRd than VRd-only (75% vs. 61%); this was also true for minimal residual disease (MRD)–negative status (58% vs. 44%, respectively). Other findings include:
- Median treatment duration: isa-VRd, 53 months; VRd-only, 31 months
- Rate of grade 3 or higher infections: isa-VRd, 45%; VRd-only, 38%
- Second primary malignancies: isa-VRd, 8%; VRd-only, 4%
- Treatment-associated deaths (mostly infectious, including COVID-19): isa-VRd, 11.0%; VRd-only, 5.5%
Comment
These positive results parallel those seen in a separate phase 3 study comparing the anti-CD38 monoclonal daratumumab plus Rd versus Rd alone and support the use of isa-VRd in transplant-ineligible patients with multiple myeloma. The numerically higher infection rates with isa-VRd than VRd-only reflect in part the longer duration of isa-Rd therapy; the higher second primary cancer rates warrant follow-up and reporting. MRD-based, risk-adapted therapy durations or antimicrobial prophylaxis might mitigate some early and late complications.
Citation(s)
Author:
Facon T et al.
Title:
Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma.
Source:
N Engl J Med
2024
Jun
3; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Michael E. Williams, MD, ScM