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000294902 1001_ $$00000-0002-6226-1252$$aMai, Elias K$$b0
000294902 245__ $$aIsatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial.
000294902 260__ $$aAlexandria, Va.$$bAmerican Society of Clinical Oncology$$c2025
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000294902 500__ $$a2025 Apr 10;43(11):1279-1288
000294902 520__ $$aPreviously, addition of isatuximab (Isa) to standard-of-care lenalidomide-bortezomib-dexamethasone (RVd) in transplant-eligible patients with newly diagnosed multiple myeloma in the GMMG-HD7 trial (ClinicalTrials.gov identifier: NCT03617731) resulted in a significant increase of minimal residual disease negativity (MRD-) rates after induction therapy. A total of 662 patients were randomly assigned to receive induction therapy with Isa-RVd (n = 331) or RVd (n = 329), followed by single or tandem autologous stem-cell transplant and second random assignment to maintenance with lenalidomide alone or Isa-lenalidomide. We report updated results for part 1 from first random assignment to post-transplant. As of January 31, 2024, MRD- rates continued to deepen after transplant (66% Isa-RVd v 48% RVd). Isa-RVd induction therapy significantly prolonged progression-free survival (PFS) compared with RVd regardless of maintenance therapy (hazard ratio, 0.70 [95% CI, 0.52 to 0.95]; P = .0184). Weighted risk set estimator analysis accounting for second random assignment followed by maintenance with only lenalidomide confirmed a statistically significant benefit for Isa-RVd followed by lenalidomide maintenance versus RVd followed by lenalidomide maintenance (stratified weighted log-rank test P = .016). In conclusion, after 18-week induction therapy followed by transplant without consolidation therapy, adding Isa to RVd resulted in a significant PFS benefit, regardless of maintenance strategy.
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000294902 7001_ $$00000-0001-5584-3951$$aBertsch, Uta$$b1
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000294902 7001_ $$aBesemer, Britta$$b4
000294902 7001_ $$aHanoun, Christine$$b5
000294902 7001_ $$00000-0003-2744-5491$$aSchroers, Roland$$b6
000294902 7001_ $$avon Metzler, Ivana$$b7
000294902 7001_ $$aHänel, Mathias$$b8
000294902 7001_ $$00000-0002-7823-8428$$aMann, Christoph$$b9
000294902 7001_ $$00000-0002-9248-588X$$aLeypoldt, Lisa B$$b10
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000294902 7001_ $$aTichy, Diana$$b19
000294902 7001_ $$00000-0002-2474-523X$$aHolderried, Tobias A W$$b20
000294902 7001_ $$00000-0002-9050-1049$$aTrautmann-Grill, Karolin$$b21
000294902 7001_ $$aGezer, Deniz$$b22
000294902 7001_ $$aKlaiber-Hakimi, Maika$$b23
000294902 7001_ $$aMüller, Martin$$b24
000294902 7001_ $$00000-0003-0178-1729$$aShumilov, Evgenii$$b25
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000294902 7001_ $$00000-0001-9422-6614$$aWeisel, Katja C$$b34
000294902 7001_ $$00000-0001-7803-0814$$aSalwender, Hans J$$b35
000294902 7001_ $$aGoldschmidt, Hartmut$$b36
000294902 7001_ $$aGroup, German-Speaking Myeloma Multicenter$$b37$$eCollaboration Author
000294902 7001_ $$aGroup, German-speaking Myeloma Multicenter$$b38$$eCollaboration Author
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