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Bending the Curve Trial by Trial
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GMMG-HD7

Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1

Phase 3N = 660NCT03617731

Population
Newly diagnosed multiple myeloma, aged 18 to 70 years, eligible for induction, high-dose melphalan with autologous transplantation and maintenance; 660 in the ITT analysis.
Design
Open-label, multicentre, randomised, active-controlled phase 3 trial at 67 centres in Germany, reported in two parts; part 1 compares three 42-day cycles of induction with isatuximab plus RVd or RVd alone. The primary end point was MRD negativity by flow cytometry after induction in the intention-to-treat population. Part 2 results are not covered here.
Primary endpoint
MRD
Arms
  • Isatuximab + RVd (experimental, n = 331): Isatuximab 10 mg/kg with lenalidomide, bortezomib and dexamethasone induction, three 42-day cycles
  • RVd (control, n = 329): Lenalidomide, bortezomib and dexamethasone induction, three 42-day cycles
People
Goldschmidt H
Δ MRD+14 points
Show the numbers
Results reported for GMMG-HD7
EndpointAnalysisIsatuximab + RVdRVdEffect
MRDITT population (660)primaryGoldschmidt 202250%36%P=0.00017MRD negativity by flow cytometry after induction. Odds ratio 1.82 (95% CI 1.33 to 2.48). Grade 3 or 4 neutropenia occurred in 77 (23%) versus 23 (7%) and grade 3 or 4 infections in 40 (12%) versus 32 (10%).
Results reported for GMMG-HD7
EndpointAnalysisIsatuximab + RVdRVdEffect
MRDITT population (660)primaryGoldschmidt 202250%36%P=0.00017MRD negativity by flow cytometry after induction. Odds ratio 1.82 (95% CI 1.33 to 2.48). Grade 3 or 4 neutropenia occurred in 77 (23%) versus 23 (7%) and grade 3 or 4 infections in 40 (12%) versus 32 (10%).
Primary publication: Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022;9(11):e810-e821. PubMedDOI

Appears in

Sources

  1. Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022;9(11):e810-e821.

    PubMedDOI