NOTE

🌱 created from: treatment of multiple myeloma (MM)

perseus

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PERSEUS: D-VRd (daratumumab + VRd) vs VRd, PFS at 48 months: 84.3% vs 67.7% (HR 0.42, P<0.001); Grade 3/4 neutropenia: 62.1% vs 51.0%, thrombocytopenia: 29.1% vs 17.3%.

Daratumumab Plus VRd in Transplantation-Eligible Patients with Newly Diagnosed Multiple Myeloma

Information

• Design: Phase 3, randomized, controlled, multi-center
• Number of patients: 709
• Patients characteristics: Transplantation-eligible patients with newly diagnosed multiple myeloma
• Agent: Subcutaneous daratumumab combined with bortezomib, lenalidomide, and dexamethasone (D-VRd) vs VRd alone
• Treatment line: First-line therapy
• Trial Name or NCT Number: PERSEUS (NCT03710603, EudraCT 2018-002992-16)

Comparison of two groups

Endpoint	D-VRd	VRd
Progression-Free Survival at 48 months	84.3%	67.7%
Hazard Ratio for Disease Progression or Death	0.42 (95% CI, 0.30 to 0.59); P<0.001	-
Complete Response or Better	87.9%	70.1%; P<0.001
Minimal Residual Disease (MRD)–Negative Status	75.2%	47.5%; P<0.001

Other findings

• Death occurred in 34 patients in the D-VRd group and 44 patients in the VRd group
• Grade 3 or 4 adverse events occurred in most patients in both groups, with neutropenia and thrombocytopenia being the most common
• Serious adverse events occurred in 57.0% of patients in the D-VRd group and 49.3% of those in the VRd group

Summary In this phase 3 trial, the addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy significantly improved progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma. The D-VRd group also had higher rates of complete response or better and MRD-negative status compared to the VRd group.