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GMMG-HD6 Study: Bortezomib, Lenalidomide, and Dexamethasone with or without Elotuzumab for Patients with Newly Diagnosed MM

2020 Year in Review - Multiple Myeloma

The GMMG-HD6 study, an ongoing phase 3, randomized, open-label, multicenter trial, examines the effect of bortezomib, lenalidomide, and dexamethasone (VRD) with or without the addition of elotuzumab as induction therapy for newly diagnosed transplant-eligible patients with multiple myeloma (MM).

The trial will primarily evaluate whether the addition of elotuzumab to a high-dose chemotherapy regimen of VRD can improve progression-free survival compared with the same regimen without elotuzumab. Secondary end points of overall survival and complete response rates after the induction therapy will compare the VRD arm with the VRD + elotuzumab arm. The safety profile will also be evaluated.

The study design includes 4 groups of patients randomized into 4 study arms: A1, A2, B1, and B2. Patients in the A1 and A2 arms (N = 280) receive four 21-day induction cycles of VRD, and patients in arms B1 and B2 (N = 279) are administered the same VRD regimen with the addition of elotuzumab. The baseline characteristics of the patients include a median age of 59 years (range, 27-70 years), with International Staging System stages, high-risk cytogenetics including del(7p13), t(4;14), or >3 copies of 1q21, and proportion of patients with renal impairment being equally distributed among the arms; ≥4 induction cycles were completed by 94.3% of the VRD group and 92.5% of the VRD + elotuzumab group. For 21 patients in the VRD group and 25 patients in the VRD + elotuzumab group, discontinuation until 30 days after induction therapy occurred because of toxicity, progressive disease, death, or withdrawal of consent.

After the fourth cycle of induction therapy with VRD or VRD + elotuzumab, overall response rates (≥partial response) were 85.6% and 82.4% in the VRD and VRD + elotuzumab  groups, respectively. In 54.0% of patients given VRD and 58.3% of patients given VRD + elotuzumab, very good partial response or better was achieved. In 3.6% of patients given VRD and 2.9% of patients given VRD + elotuzumab, complete response was achieved.

During the induction period, ≥1 adverse events (any grade) were observed in 66.5% of the safety population of the VRD group and in 65.4% of the safety population of the VRD + elotuzumab group (VRD: N = 183/275, 66.5% vs VRD + elotuzumab: N = 183/280, 65.4%; P = .79). Most common system organ classes were nervous system disorders (VRD: 24.0% vs VRD + elotuzumab: 23.6%; P = .92), infections and infestations (VRD: 22.9% vs VRD + elotuzumab: 20.0%; P = .41), and blood and lymphatic system disorders (VRD: 8.4% vs VRD + elotuzumab: 14.6%; P = .02). In the VRD group, there were 4 deaths; in the VRD + elotuzumab group related to the induction therapy, there were 9 deaths.

For newly diagnosed patients with MM, the addition of elotuzumab to VRD for 4 induction cycles did not increase the rate of very good partial response or better after 4 induction cycles. To assess overall response rates, evaluation of patients at later time points will occur in further trial analysis.

Reference
Abstract and Presentation S203. EHA 2020. June 12, 2020. Bortezomib, lenalidomide and dexamethasone with or without elotuzumab as induction therapy for newly diagnosed, transplant-eligible multiple myeloma.

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