دورية أكاديمية
Daratumumab in transplant-eligible patients with newly diagnosed multiple myeloma: final analysis of clinically relevant subgroups in GRIFFIN.
العنوان: | Daratumumab in transplant-eligible patients with newly diagnosed multiple myeloma: final analysis of clinically relevant subgroups in GRIFFIN. |
---|---|
المؤلفون: | Chari A; Icahn School of Medicine at Mount Sinai, New York, NY, USA. ajai.chari@ucsf.edu., Kaufman JL; Winship Cancer Institute, Emory University, Atlanta, GA, USA., Laubach J; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Sborov DW; Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, UT, USA., Reeves B; University of North Carolina-Department of Medicine-Chapel Hill, Chapel Hill, NC, USA., Rodriguez C; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Silbermann R; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA., Costa LJ; University of Alabama at Birmingham, Birmingham, AL, USA., Anderson LD Jr; Myeloma, Waldenstrӧm's and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA., Nathwani N; Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA., Shah N; University of California San Francisco, San Francisco, CA, USA., Bumma N; Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA., Holstein SA; Division of Oncology and Hematology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA., Costello C; Moores Cancer Center, University of California San Diego, La Jolla, CA, USA., Jakubowiak A; University of Chicago Medical Center, Chicago, IL, USA., Wildes TM; Division of Oncology and Hematology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA., Orlowski RZ; Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Shain KH; Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL, USA., Cowan AJ; Clinical Research Division, Fred Hutch Cancer Center, Seattle, WA, USA., Pei H; Janssen Research & Development, LLC, Titusville, NJ, USA., Cortoos A; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Patel S; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Lin TS; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Voorhees PM; Levine Cancer Institute, Atrium Health Wake Forest University School of Medicine, Charlotte, NC, USA. Peter.Voorhees@atriumhealth.org., Usmani SZ; Memorial Sloan Kettering Cancer Center, New York, NY, USA. usmanis@mskcc.org., Richardson PG; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. |
المصدر: | Blood cancer journal [Blood Cancer J] 2024 Jul 08; Vol. 14 (1), pp. 107. Date of Electronic Publication: 2024 Jul 08. |
نوع المنشور: | Journal Article; Clinical Trial, Phase II; Randomized Controlled Trial; Multicenter Study |
اللغة: | English |
بيانات الدورية: | Publisher: Nature Pub. Group Country of Publication: United States NLM ID: 101568469 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-5385 (Electronic) Linking ISSN: 20445385 NLM ISO Abbreviation: Blood Cancer J Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: New York, NY : Nature Pub. Group |
مواضيع طبية MeSH: | Multiple Myeloma*/drug therapy , Multiple Myeloma*/mortality , Multiple Myeloma*/therapy , Multiple Myeloma*/diagnosis , Antibodies, Monoclonal*/therapeutic use , Antibodies, Monoclonal*/administration & dosage , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/adverse effects, Humans ; Aged ; Female ; Male ; Middle Aged ; Adult ; Dexamethasone/administration & dosage ; Dexamethasone/therapeutic use ; Bortezomib/therapeutic use ; Bortezomib/administration & dosage ; Lenalidomide/therapeutic use ; Lenalidomide/administration & dosage |
مستخلص: | The randomized, phase 2 GRIFFIN study (NCT02874742) evaluated daratumumab plus lenalidomide/bortezomib/dexamethasone (D-RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM). We present final post hoc analyses (median follow-up, 49.6 months) of clinically relevant subgroups, including patients with high-risk cytogenetic abnormalities (HRCAs) per revised definition (del[17p], t[4;14], t[14;16], t[14;20], and/or gain/amp[1q21]). Patients received 4 induction cycles (D-RVd/RVd), high-dose therapy/transplant, 2 consolidation cycles (D-RVd/RVd), and lenalidomide±daratumumab maintenance (≤ 2 years). Minimal residual disease-negativity (10 -5 ) rates were higher for D-RVd versus RVd in patients ≥ 65 years (67.9% vs 17.9%), with HRCAs (54.8% vs 32.4%), and with gain/amp(1q21) (61.8% vs 28.6%). D-RVd showed a trend toward improved progression-free survival versus RVd (hazard ratio [95% confidence interval]) in patients ≥ 65 years (0.29 [0.06-1.48]), with HRCAs (0.38 [0.14-1.01]), and with gain/amp(1q21) (0.42 [0.14-1.27]). In the functional high-risk subgroup (not MRD negative at the end of consolidation), the hazard ratio was 0.82 (0.35-1.89). Among patients ≥ 65 years, grade 3/4 treatment-emergent adverse event (TEAE) rates were higher for D-RVd versus RVd (88.9% vs 77.8%), as were TEAEs leading to discontinuation of ≥ 1 treatment component (37.0% vs 25.9%). One D-RVd patient died due to an unrelated TEAE. These results support the addition of daratumumab to RVd in transplant-eligible patients with high-risk NDMM. Video Abstract. (© 2024. The Author(s).) |
References: | N Engl J Med. 2018 Feb 8;378(6):518-528. (PMID: 29231133) Haematologica. 2021 Jul 01;106(7):2004-2008. (PMID: 33440920) Leukemia. 2019 Jan;33(1):159-170. (PMID: 29967379) Lancet Haematol. 2023 Oct;10(10):e825-e837. (PMID: 37708911) Haematologica. 2020 Jun 05;105(9):e480-483. (PMID: 33054068) Oncologist. 2022 Jul 5;27(7):e589-e596. (PMID: 35462406) JAMA Oncol. 2020 Nov 01;6(11):1759-1765. (PMID: 32970151) Lancet. 2019 Jul 6;394(10192):29-38. (PMID: 31171419) Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):785-798. (PMID: 34344638) Am J Hematol. 2024 Jul;99(7):1257-1268. (PMID: 38622840) N Engl J Med. 2024 Jan 25;390(4):301-313. (PMID: 38084760) Blood. 2016 Jun 16;127(24):2955-62. (PMID: 27002115) Am Soc Clin Oncol Educ Book. 2021 Mar;41:291-309. (PMID: 34010042) Lancet Oncol. 2016 Aug;17(8):e328-e346. (PMID: 27511158) EJHaem. 2020 Jul 02;1(1):267-271. (PMID: 35847747) J Immunol. 2016 Aug 1;197(3):807-13. (PMID: 27316683) Leukemia. 2022 Apr;36(4):1066-1077. (PMID: 34974527) J Immunol. 2011 Feb 1;186(3):1840-8. (PMID: 21187443) Leukemia. 2021 Feb;35(2):573-584. (PMID: 32457357) Expert Rev Hematol. 2021 Dec;14(12):1099-1114. (PMID: 34551651) Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):30-36. (PMID: 34889431) MAbs. 2015;7(2):311-21. (PMID: 25760767) Lancet Haematol. 2023 Nov;10(11):e890-e901. (PMID: 37776872) Am J Hematol. 2021 Jul 1;96(7):854-871. (PMID: 33725367) Leukemia. 2014 Feb;28(2):269-77. (PMID: 23974982) Mayo Clin Proc. 2004 Jul;79(7):867-74. (PMID: 15244382) J Clin Oncol. 2022 Oct 10;40(29):3406-3418. (PMID: 35605179) Blood. 2020 Aug 20;136(8):936-945. (PMID: 32325490) Lancet Oncol. 2021 Nov;22(11):1582-1596. (PMID: 34655533) Haematologica. 2022 Oct 01;107(10):2485-2491. (PMID: 35734925) Fac Rev. 2022 Sep 29;11:28. (PMID: 36225211) Cytometry A. 2019 Mar;95(3):279-289. (PMID: 30536810) N Engl J Med. 2022 Jul 14;387(2):132-147. (PMID: 35660812) Haematologica. 2017 May;102(5):910-921. (PMID: 28154088) BMC Cancer. 2021 Jun 2;21(1):659. (PMID: 34078314) Blood Cancer J. 2022 Jan 31;12(1):24. (PMID: 35102139) Br J Haematol. 2021 Jul;194(1):120-131. (PMID: 34036560) J Natl Compr Canc Netw. 2020 Dec 02;18(12):1730-1737. (PMID: 33285523) Blood. 2016 Jul 21;128(3):384-94. (PMID: 27222480) |
المشرفين على المادة: | 4Z63YK6E0E (daratumumab) 0 (Antibodies, Monoclonal) 7S5I7G3JQL (Dexamethasone) 69G8BD63PP (Bortezomib) F0P408N6V4 (Lenalidomide) |
تواريخ الأحداث: | Date Created: 20240708 Date Completed: 20240708 Latest Revision: 20240711 |
رمز التحديث: | 20240711 |
مُعرف محوري في PubMed: | PMC11231363 |
DOI: | 10.1038/s41408-024-01088-6 |
PMID: | 38977707 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2044-5385 |
---|---|
DOI: | 10.1038/s41408-024-01088-6 |