5,024
Views
5
CrossRef citations to date
0
Altmetric
Original Articles

Relative efficacy of treatment options in transplant-ineligible newly diagnosed multiple myeloma: results from a systematic literature review and network meta-analysis

, , , , , & show all
Pages 668-679 | Received 07 May 2019, Accepted 13 Oct 2019, Published online: 11 Nov 2019

References

  • Moreau P, San Miguel J, Sonneveld P, et al. Multiple myeloma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28 (suppl_4):iv52–iv61.
  • National Comprehensive Cancer Network, Inc. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.1.2020; 2019. [cited 2019 Oct 3]. Available from: NCCN.org.
  • Tonin FS, Rotta I, Mendes AM, et al. Network meta-analysis: a technique to gather evidence from direct and indirect comparisons. Pharm Pract. 2017;15(1):943.
  • Weisel K, Doyen C, Dimopoulos M, et al. A systematic literature review and network meta-analysis of treatments for patients with untreated multiple myeloma not eligible for stem cell transplantation. Leuk Lymphoma. 2017;58(1):153–161.
  • Centre for Reviews and Dissemination. Systematic reviews: CRD’s guidance for undertaking reviews in health care. York: University of York; 2009.
  • Jansen JP, Cope S. Meta-regression models to address heterogeneity and inconsistency in network meta-analysis of survival outcomes. BMC Med Res Methodol. 2012;12(1):152–152.
  • Tierney JF, Stewart LA, Ghersi D, et al. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials. 2007;8(1):16.
  • Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
  • Dias S, Sutton AJ, Ades AE, et al. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013;33(5):607–617.
  • Palumbo A, Hajek R, Delforge M, et al. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012;366(19):1759–1769.
  • Facon T, Dimopoulos MA, Dispenzieri A, et al. Final analysis of overall survival from the First trial. Blood. 2016;128(22):241.
  • Salanti G, Del Giovane C, Chaimani A, et al. Evaluating the quality of evidence from a network meta-analysis. PLoS One. 2014;9(7):e99682.
  • Chaimani A, Higgins JP, Mavridis D, et al. Graphical tools for network meta-analysis in STATA. PLoS One. 2013;8(10):e76654.
  • Dias S, Sutton AJ, Welton NJ, et al. Evidence synthesis for decision making 3: heterogeneity–subgroups, meta-regression, bias, and bias-adjustment. Med Decis Making. 2013;33(5):618–640.
  • Durie BGM, Hoering A, Abidi M, 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.
  • Facon T, Mary JY, Hulin C, 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):1209–1218.
  • Facon T, Dimopoulos MA, Hulin C, et al. Updated overall survival analysis of the FIRST study: continuous lenalidomide plus low-dose dexamethasone vs melphalan, prednisone, and thalidomide in patients with newly diagnosed multiple myeloma. Haematologica. 2015;100(3):Abstract S105.
  • Facon T, Dimopoulos MA, Dispenzieri A, et al. Final survival analysis from the FIRST trial: lenalidomide plus low-dose dexamethasone until progression (Rd cont) v melphalan, prednisone and thalidomide (MPT), and Rd for 18 cycles (Rd18) for transplant-ineligible (TNE) patients (pts) with newly diagnosed multiple myeloma. Clin Lymphoma Myeloma Leuk. 2017;17(suppl 1):e63–e64.
  • Hulin C, Facon T, Rodon P, et al. Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. JCO. 2009;27(22):3664–3670.
  • Fayers PM, Palumbo A, Hulin C, et al. Thalidomide for previously untreated elderly patients with multiple myeloma: meta-analysis of 1685 individual patient data from 6 randomized clinical trials. Blood. 2011;118(5):1239–1247.
  • Sacchi S, Marcheselli R, Lazzaro A, et al. A randomized trial with melphalan and prednisone versus melphalan and prednisone plus thalidomide in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant. Leuk Lymphoma. 2011;52(10):1942–1948.
  • San Miguel JF, Schlag R, Khuageva NK, et al. Persistent overall survival benefit and no increased risk of second malignancies with bortezomib-melphalan-prednisone versus melphalan-prednisone in patients with previously untreated multiple myeloma. JCO. 2013;31(4):448–455.
  • Benboubker L, Dimopoulos MA, Dispenzieri A, et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014;371(10):906–917.
  • Mateos M-V, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018;378(6):518–528.
  • Facon T, Kumar S, Plesner T, et al. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104–2115.
  • Ludwig H, Hajek R, Tothova E, et al. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009;113(15):3435–3442.
  • Facon T, Lee JH, Moreau P, et al. Phase 3 study (CLARION) of carfilzomib, melphalan, prednisone (KMP) v bortezomib, melphalan, prednisone (VMP) in newly diagnosed multiple myeloma (NDMM). Clin Lymphoma Myeloma Leuk. 2017;17(1):e26–e27.
  • Stewart AK, Jacobus S, Fonseca R, et al. Melphalan, prednisone, and thalidomide vs melphalan, prednisone, and lenalidomide (ECOG E1A06) in untreated multiple myeloma. Blood. 2015;126(11):1294–1301.
  • Mateos MV, Oriol A, Martínez-López J, et al. Bortezomib, melphalan, and prednisone versus bortezomib, thalidomide, and prednisone as induction therapy followed by maintenance treatment with bortezomib and thalidomide versus bortezomib and prednisone in elderly patients with untreated multiple myeloma: a randomised trial. Lancet Oncol. 2010;11(10):934–941.
  • Mateos M-V, Oriol A, Martínez-López J, et al. GEM2005 trial update comparing VMP/VTP as induction in elderly multiple myeloma patients: do we still need alkylators? Blood. 2014;124(12):1887–1893.
  • Palumbo A, Bringhen S, Liberati AM, et al. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008;112(8):3107–3114.
  • Palumbo A, Bringhen S, Larocca A, et al. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. JCO. 2014;32(7):634–640.
  • Wijermans P, Schaafsma M, Termorshuizen F, et al. Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 study. JCO. 2010;28(19):3160–3166.
  • Zweegman S, van der Holt B, Mellqvist U-H, et al. Lenalidomide plus melphalan and prednisone, followed by lenalidomide maintenance versus thalidomide plus melphalan and prednisone, followed by thalidomide maintenance; results of the randomized phase 3 HOVON87/NMSG18 trial. Blood. 2016;127(9):1109–1116.
  • Zweegman S, van der Holt B, Mellqvist U-H, et al. Randomized phase III trial in non-transplant eligible patients with newly diagnosed symptomatic multiple myeloma comparing melphalan-prednisone-thalidomide followed by thalidomide maintenance (MPT-T) versus melphalan-prednisone-lenalidomide followed by maintenance with lenalidomide (MPR-R); a joint study of the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and the Nordic Myeloma Study Group (NMSG). Blood. 2014;124(21):179.
  • Hungria VT, Crusoe EQ, Maiolino A, et al. Phase 3 trial of three thalidomide-containing regimens in patients with newly diagnosed multiple myeloma not transplant-eligible. Ann Hematol. 2016;95(2):271–278.
  • Facon T, Mary JY, Pegourie B, et al. Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood. 2006;107(4):1292–1298.
  • Magarotto V, Bringhen S, Offidani M, et al. Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma. Blood. 2016;127(9):1102–1108.
  • Morgan GJ, Davies FE, Gregory WM, et al. Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. Blood. 2011;118(5):1231–1238.
  • Pawlyn C, Davies FE, Cairns D, et al. Continuous treatment with lenalidomide improves outcomes in newly-diagnosed myeloma patients not eligible for autologous stem cell transplant: results of the Myeloma XI trial. Blood. 2017;130:1854.
  • Waage A, Gimsing P, Fayers P, et al. Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. 2010;116(9):1405–1412.
  • San-Miguel J, Blade J, Shpilberg O, et al. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014;123(26):4136–4142.
  • Beksac M, Haznedar R, Firatli-Tuglular T, et al. Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Group. Eur J Haematol. 2011;86(1):16–22.
  • Niezivsky R, Flinn IW, Rifkin R, et al. Community-based phase IIIB trial of three UPFRONT bortezomib-based myeloma regimens. JCO. 2015;33:3921–3929.
  • Kapoor P, Rajkumar SV. MAIA under the microscope – bringing trial design into focus. Nat Rev Clin Oncol. 2019;16(6):339–340.
  • Durie BGM, Hoering A, Abidi M, et al. Longer term follow up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT). Blood. 2018;132(suppl 1):Abstract 1992.
  • Dimopoulos MA, Mateos MV, Cavo M, et al. One-year update of a phase 3 randomized study of daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) versus bortezomib, melphalan, and prednisone (VMP) in patients (pts) with transplant-ineligible newly diagnosed multiple myeloma (NDMM): ALCYONE. Blood. 2018;132:Abstract 156.
  • Liu X, Chen J, He YA, et al. Comparing efficacy and survivals of initial treatments for elderly patients with newly diagnosed multiple myeloma: a network meta-analysis of randomized controlled trials. OTT. 2016;10:121–128.
  • Blommestein HM, van Beurden-Tan CHY, Franken MG, et al. Efficacy of first-line treatments for multiple myeloma patients not eligible for stem cell transplantation - a network meta-analysis. Haematologica. 2019;104(5):1026.
  • Cipriani A, Higgins JO, Geddes JR, et al. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159(2):130–137.
  • Lu G, Ades AE, Sutton AJ, et al. Meta-analysis of mixed treatment comparisons at multiple follow-up times. Statist Med. 2007;26(20):3681–3699.
  • Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Med Res Methodol. 2011;11(1):61.
  • Dias S, Welton N, Sutton A, et al. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making. 2013;33(5):641–656.
  • CHMP post-authorisation summary of positive opinion for Revlimid (II-102-G). [cited 2019 Mar 28]. Available from: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revlimid-ii-102-g_en.pdf.
  • Palumbo A, Bringhen S, Ludwig H, et al. Personalized therapy in multiple myeloma according to patient age and vulnerability: a report of the European Myeloma Network (EMN). Blood. 2011;118(17):4519–4529.