Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE.
Adolescent
Adult
Aged
Animals
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Biomarkers
Biopsy
Bone Marrow
/ pathology
Chromosome Aberrations
Combined Modality Therapy
Female
Hematopoietic Stem Cell Transplantation
/ adverse effects
Humans
Kaplan-Meier Estimate
Male
Mice
Middle Aged
Multiple Myeloma
/ diagnosis
Neoplasm Staging
Prognosis
Proportional Hazards Models
Salvage Therapy
Transplantation, Autologous
Treatment Outcome
Young Adult
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
12
04
2020
accepted:
23
06
2020
revised:
20
06
2020
pubmed:
23
7
2020
medline:
1
5
2021
entrez:
23
7
2020
Statut:
ppublish
Résumé
The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m
Identifiants
pubmed: 32694619
doi: 10.1038/s41375-020-0948-0
pii: 10.1038/s41375-020-0948-0
doi:
Substances chimiques
Biomarkers
0
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1134-1144Références
Gay F, Engelhardt M, Terpos E, Wäsch R, Giaccone L, Auner HW, et al. From transplant to novel cellular therapies in multiple myeloma: EMN guidelines and future perspectives. Haematologica. 2017;103:197-211.
doi: 10.3324/haematol.2017.174573
Kumar SK, Callander NS, Alsina M, Atanackovic D, Biermann JS, Chandler JC, et al. Multiple myeloma, version 3.2017, NCCN Clinical Practice Guidelines in oncology. J Natl Compr Canc Netw. 2017;15:230–69.
doi: 10.6004/jnccn.2017.0023
Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome. N Engl J Med. 1996;335:91–7.
doi: 10.1056/NEJM199607113350204
Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003;348:1875–83.
doi: 10.1056/NEJMoa022340
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;376:1311–20.
doi: 10.1056/NEJMoa1611750
Cavo M, Palumbo Antonio, Zweegman Sonja, Dimopoulos Meletios A, Hajek Roman, Pantani Lucia, et al. Upfront autologous stem cell transplantation (ASCT) versus novel agent-based therapy for multiple myeloma (MM): a randomized phase 3 study of the European Myeloma Network (EMN02/HO95 MM trial). J Clin Oncol. 2016;34:8000-8000.
doi: 10.1200/JCO.2016.34.15_suppl.8000
Atanackovic D, Schilling G. Second autologous transplant as salvage therapy in multiple myeloma. Br J Haematol. 2013;163:565–72.
doi: 10.1111/bjh.12579
Cook G, Williams C, Brown JM, Cairns DA, Cavenagh J, Snowden JA, et al. High-dose chemotherapy plus autologous stem-cell transplantation as consolidation therapy in patients with relapsed multiple myeloma after previous autologous stem-cell transplantation (NCRI Myeloma X Relapse [Intensive trial]): a randomised, open-label. Lancet Oncol. 2014;15:874–85.
doi: 10.1016/S1470-2045(14)70245-1
Cook G, Ashcroft AJ, Cairns DA, Williams CD, Brown JM, Cavenagh JD, et al. The effect of salvage autologous stem-cell transplantation on overall survival in patients with relapsed multiple myeloma (final results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open-label, phase 3 trial. Lancet Haematol. 2016;3:e340–51.
doi: 10.1016/S2352-3026(16)30049-7
Baertsch M-A, Schlenzka J, Mai EK, Merz M, Hillengaß J, Raab MS, et al. Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantatio. BMC Cancer. 2016;16:290.
doi: 10.1186/s12885-016-2321-2
Durie BGM, Harousseau J-L, Miguel JS, Bladé J, Barlogie B, Anderson K, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20:1467–73.
doi: 10.1038/sj.leu.2404284
Baertsch M-A, Schlenzka J, Lisenko K, Krzykalla J, Becker N, Weisel K, et al. Cyclophosphamide-based stem cell mobilization in relapsed multiple myeloma patients: a subgroup analysis from the phase III trial ReLApsE. Eur J Haematol. 2017;99. https://doi.org/10.1111/ejh.12888 .
Bladé J, Samson D, Reece D, Apperley J, Björkstrand B, Gahrton G, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998;102:1115–23.
doi: 10.1046/j.1365-2141.1998.00930.x
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;348:2609–17.
doi: 10.1056/NEJMoa030288
Neben K, Jauch A, Bertsch U, Heiss C, Hielscher T, Seckinger A, et al. Combining information regarding chromosomal aberrations t(4;14) and del(17p13) with the International Staging System classification allows stratification of myeloma patients undergoing autologous stem cell transplantation. Haematologica. 2010;95:1150–7.
doi: 10.3324/haematol.2009.016436
van Buuren S, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat softw. 2011;45:1–67.
doi: 10.18637/jss.v045.i03
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;357:2133–42.
doi: 10.1056/NEJMoa070596
Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau J-L, Dmoszynska A, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357:2123–32.
doi: 10.1056/NEJMoa070594
Stadtmauer EA, Weber DM, Niesvizky R, Belch A, Prince MH, San Miguel JF, et al. Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma. Eur J Haematol. 2009;82:426–32.
doi: 10.1111/j.1600-0609.2009.01257.x
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;11:29–37.
doi: 10.1016/S1470-2045(09)70284-0
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;370:1209–18.
doi: 10.1016/S0140-6736(07)61537-2
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;375:1319–31.
doi: 10.1056/NEJMoa1607751
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. 2014;372:141206080130007.
Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373:621–31.
doi: 10.1056/NEJMoa1505654
Moreau P, Masszi T, Grzasko N, Bahlis NJ, Hansson M, Pour L, et al. Oral Ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374:1621–34.
doi: 10.1056/NEJMoa1516282
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;366:1782–91.
doi: 10.1056/NEJMoa1114138
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;366:1770–81.
doi: 10.1056/NEJMoa1114083
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;35:3279–89.
doi: 10.1200/JCO.2017.72.6679