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| 100 | 1 | _ | |a Mai, Elias K |0 0000-0002-6226-1252 |b 0 |
| 245 | _ | _ | |a Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial. |
| 260 | _ | _ | |a Alexandria, Va. |c 2025 |b American Society of Clinical Oncology |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1744115762_30685 |2 PUB:(DE-HGF) |
| 336 | 7 | _ | |a ARTICLE |2 BibTeX |
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| 336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
| 500 | _ | _ | |a 2025 Apr 10;43(11):1279-1288 |
| 520 | _ | _ | |a Previously, 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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| 700 | 1 | _ | |a Hanoun, Christine |b 5 |
| 700 | 1 | _ | |a Schroers, Roland |0 0000-0003-2744-5491 |b 6 |
| 700 | 1 | _ | |a von Metzler, Ivana |b 7 |
| 700 | 1 | _ | |a Hänel, Mathias |b 8 |
| 700 | 1 | _ | |a Mann, Christoph |0 0000-0002-7823-8428 |b 9 |
| 700 | 1 | _ | |a Leypoldt, Lisa B |0 0000-0002-9248-588X |b 10 |
| 700 | 1 | _ | |a Heilmeier, Bernhard |b 11 |
| 700 | 1 | _ | |a Huhn, Stefanie |b 12 |
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| 700 | 1 | _ | |a Holderried, Tobias A W |0 0000-0002-2474-523X |b 20 |
| 700 | 1 | _ | |a Trautmann-Grill, Karolin |0 0000-0002-9050-1049 |b 21 |
| 700 | 1 | _ | |a Gezer, Deniz |b 22 |
| 700 | 1 | _ | |a Klaiber-Hakimi, Maika |b 23 |
| 700 | 1 | _ | |a Müller, Martin |b 24 |
| 700 | 1 | _ | |a Shumilov, Evgenii |0 0000-0003-0178-1729 |b 25 |
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| 700 | 1 | _ | |a Michel, Christian S |0 0009-0004-1596-3763 |b 27 |
| 700 | 1 | _ | |a Geer, Thomas |b 28 |
| 700 | 1 | _ | |a Riesenberg, Hendrik |b 29 |
| 700 | 1 | _ | |a Lutz, Christoph |b 30 |
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| 700 | 1 | _ | |a Salwender, Hans J |0 0000-0001-7803-0814 |b 35 |
| 700 | 1 | _ | |a Goldschmidt, Hartmut |b 36 |
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