References: Multiple myeloma
158 sources cited on this page. Links open the primary source.
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Loading… - Myeloma Trialists' Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. J Clin Oncol. 1998;16(12):3832-42. PubMedDOI
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Loading… - Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999;341(21):1565-71. PubMedDOI
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Loading… - Attal M, Harousseau JL, Facon T, Guilhot F, Doyen C, Fuzibet JG, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med. 2003;349(26):2495-502. PubMedDOI
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Loading… - US Food and Drug Administration. Approved labeling, NDA 21-602, Velcade (bortezomib) for Injection, Millennium Pharmaceuticals, Inc.; package insert finalised 13 May 2003 (Indications and Usage section). Source
- US Food and Drug Administration. Approval letter, NDA 21-602, Velcade (bortezomib) for Injection, Millennium Pharmaceuticals, Inc.; electronically signed 13 May 2003 (R Temple, Office of Drug Evaluation 1). Source
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- Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348(26):2609-17. PubMedDOI
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Loading… - US Food and Drug Administration. Supplement approval letter, NDA 21-602/S-006, Velcade (bortezomib) for Injection, Millennium Pharmaceuticals, Inc.; electronically signed 25 March 2005 (R Pazdur, Division of Oncology Drug Products). Source
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Loading… - Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;352(24):2487-98. PubMedDOI
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Loading… - US Food and Drug Administration. Supplement approval letter, NDA 21-880/S-001, Revlimid (lenalidomide) capsules, Celgene Corporation; letter signed 29 June 2006. Source
- US Food and Drug Administration. Approval letter, NDA 21-430 and NDA 20-785/S-031, Thalomid (thalidomide) capsules, Celgene Corporation; letter signed 25 May 2006. Source
- Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin DH, et al. Extended follow-up of a phase II trial in relapsed, refractory multiple myeloma:: final time-to-event results from the SUMMIT trial. Cancer. 2006;106(6):1316-9. PubMedDOI
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Loading… - Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357(21):2123-32. PubMedDOI
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Loading… - Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, et al. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007;370(9594):1209-18. PubMedDOI
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Loading… - Richardson PG, Sonneveld P, Schuster M, Irwin D, Stadtmauer E, Facon T, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood. 2007;110(10):3557-60. PubMedDOI
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Loading… - Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007;357(21):2133-42. PubMedDOI
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Loading… - Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, et al. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008;26(13):2171-7. PubMedDOI
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Loading… - San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359(9):906-17. PubMedDOI
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Loading… - Mateos MV, Richardson PG, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, et al. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010;28(13):2259-66. PubMedDOI
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Loading… - Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, et al. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010;11(1):29-37. PubMedDOI
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Loading… - Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1782-91. PubMedDOI
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Loading… - U.S. Food and Drug Administration. Accelerated approval letter, NDA 202714 (Kyprolis, carfilzomib). 20 July 2012. Source
- McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1770-81. PubMedDOI
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Loading… - Siegel DS, Martin T, Wang M, Vij R, Jakubowiak AJ, Lonial S, et al. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012;120(14):2817-25. PubMedDOI
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Loading… - Mateos MV, Hernández MT, Giraldo P, de la Rubia J, de Arriba F, López Corral L, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-47. PubMedDOI
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Loading… - Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014;371(10):906-17. PubMedDOI
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Loading… - Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48. PubMedDOI
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Loading… - U.S. Food and Drug Administration. Replacement approval letter, BLA 761036 (Darzalex, daratumumab). Effective approval date 16 November 2015; signed 16 November 2015. Source
- U.S. Food and Drug Administration. Supplement approval letter, NDA 202714/S-009 (Kyprolis with lenalidomide and dexamethasone; fulfilment of postmarketing requirement PMR 1908-1). 24 July 2015. Source
- US Food and Drug Administration. Supplement approval letter, NDA 021880/S-041, Revlimid (lenalidomide) capsules, Celgene Corporation; letter signed 17 February 2015. Source
- Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, et al. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015;373(13):1207-19. PubMedDOI
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Loading… - Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, et al. Revised International Staging System for Multiple Myeloma: A Report From International Myeloma Working Group. J Clin Oncol. 2015;33(26):2863-9. PubMedDOI
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Loading… - Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372(2):142-52. PubMedDOI
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Loading… - Vargesson N. Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res C Embryo Today. 2015;105(2):140-56. PubMedDOI
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Loading… - Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hájek R, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17(1):27-38. PubMedDOI
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Loading… - Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(14):1319-1331. PubMedDOI
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Loading… - U.S. Food and Drug Administration. Supplement approval letter, BLA 761036/S-003 (Darzalex with lenalidomide and dexamethasone; fulfilment of postmarketing requirement). 21 November 2016. Source
- U.S. Food and Drug Administration. Supplement approval letter, BLA 761036/S-004 (Darzalex with bortezomib and dexamethasone; fulfilment of postmarketing requirement). 21 November 2016. Source
- U.S. Food and Drug Administration. Supplement approval letter, NDA 202714/S-010 (Kyprolis; regular approval of the monotherapy indication based on ENDEAVOR; Subpart H fulfilled). 21 January 2016. Source
- Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-e346. PubMedDOI
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Loading… - Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387(10027):1551-1560. PubMedDOI
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Loading… - Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(8):754-66. PubMedDOI
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Loading… - Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, et al. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017;376(14):1311-1320. PubMedDOI
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Loading… - Durie BGM, Hoering A, Abidi MH, Rajkumar SV, Epstein J, Kahanic SP, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017;389(10068):519-527. PubMedDOI
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Loading… - US Food and Drug Administration. Supplement approval letter, NDA 021880/S-049, Revlimid (lenalidomide) capsules, Celgene Corporation; letter signed 22 February 2017. Source
- McCarthy PL, Holstein SA, Petrucci MT, Richardson PG, Hulin C, Tosi P, et al. Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis. J Clin Oncol. 2017;35(29):3279-3289. PubMedDOI
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Loading… - Munshi NC, Avet-Loiseau H, Rawstron AC, Owen RG, Child JA, Thakurta A, et al. Association of Minimal Residual Disease With Superior Survival Outcomes in Patients With Multiple Myeloma: A Meta-analysis. JAMA Oncol. 2017;3(1):28-35. PubMedDOI
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Loading… - Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, et al. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018;131(3):301-310. PubMedDOI
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Loading… - U.S. Food and Drug Administration. Supplement approval letter, BLA 761036/S-013 (Darzalex with bortezomib, melphalan and prednisone, newly diagnosed, transplant-ineligible). 7 May 2018. Source
- Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018;378(6):518-528. PubMedDOI
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Loading… - Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. PubMedDOI
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Loading… - Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-2115. PubMedDOI
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Loading… - U.S. Food and Drug Administration. Supplement approval letter, BLA 761036/S-020 (Darzalex with lenalidomide and dexamethasone, newly diagnosed, transplant-ineligible). 27 June 2019. Source
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Loading… - U.S. Food and Drug Administration. Approval letter, BLA 761113 (Sarclisa, isatuximab-irfc). 2 March 2020. Source
- Kumar SK, Jacobus SJ, Cohen AD, Weiss M, Callander N, Singh AK, et al. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2020;21(10):1317-1330. PubMedDOI
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Loading… - Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, et al. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020;21(12):1630-1642. PubMedDOI
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Loading… - Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, et al. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma. J Clin Oncol. 2020;38(11):1126-1137. PubMedDOI
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Loading… - Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207-221. PubMedDOI
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Loading… - Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020;136(8):936-945. PubMedDOI
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Loading… - Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324. PubMedDOI
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Loading… - Dimopoulos MA, Moreau P, Terpos E, Mateos MV, Zweegman S, Cook G, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(†). Ann Oncol. 2021;32(3):309-322. PubMedDOI
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Loading… - Chari A, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodríguez-Otero P, et al. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma. N Engl J Med. 2022;387(24):2232-2244. PubMedDOI
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Loading… - D'Agostino M, Cairns DA, Lahuerta JJ, Wester R, Bertsch U, Waage A, et al. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project. J Clin Oncol. 2022;40(29):3406-3418. PubMedDOI
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Loading… - U.S. Food and Drug Administration, CBER. Approval letter, BLA 125746 (Carvykti, ciltacabtagene autoleucel). 28 February 2022. Source
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Loading… - Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):495-505. PubMedDOI
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Loading… - European Medicines Agency. EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep. News item, 15 September 2023. Source
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Loading… - Ludwig H, Kainz S, Schreder M, Zojer N, Hinke A. SLiM CRAB criteria revisited: temporal trends in prognosis of patients with smoldering multiple myeloma who meet the definition of 'biomarker-defined early multiple myeloma'-a systematic review with meta-analysis. EClinicalMedicine. 2023;58:101910. PubMedDOI
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Loading… - Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, et al. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024;42(22):2702-2712. PubMedDOI
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Loading… - Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024;391(5):408-421. PubMedDOI
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Loading… - Facon T, Dimopoulos MA, Leleu XP, Beksac M, Pour L, Hájek R, et al. Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;391(17):1597-1609. PubMedDOI
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Loading… - Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;390(4):301-313. PubMedDOI
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Loading… - Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, et al. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025;392(18):1777-1788. PubMedDOI
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