Multiple myeloma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main multiple myeloma page for regimens that include active anticancer treatment.
Last updated on 2024-12-02:5 regimens on this page
5 variants on this page
=Consolidation after first-line therapy=
==No consolidation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Cavo et al. 2020 (EMN02/HOVON-95)	2011-2014 	Phase 3 (C)	RVD x 2 	Seems to have shorter PFS1
1Reported efficacy is based on the 2021 update.
No additional consolidation; patients proceeded directly to lenalidomide maintenance.
====Preceding treatment====
*Consolidation VMP x 4 versus High-dose melphalan & autologous hematopoietic stem cell transplant x 1 to 2
====Subsequent treatment====
*Lenalidomide maintenance
===References===
# EMN02/HOVON-95: Cavo M, Gay F, Beksac M, Pantani L, Petrucci MT, Dimopoulos MA, Dozza L, van der Holt B, Zweegman S, Oliva S, van der Velden VHJ, Zamagni E, Palumbo GA, Patriarca F, Montefusco V, Galli M, Maisnar V, Gamberi B, Hansson M, Belotti A, Pour L, Ypma P, Grasso M, Croockewit A, Ballanti S, Offidani M, Vincelli ID, Zambello R, Liberati AM, Andersen NF, Broijl A, Troia R, Pascarella A, Benevolo G, Levin MD, Bos G, Ludwig H, Aquino S, Morelli AM, Wu KL, Boersma R, Hajek R, Durian M, von dem Borne PA, Caravita di Toritto T, Zander T, Driessen C, Specchia G, Waage A, Gimsing P, Mellqvist UH, van Marwijk Kooy M, Minnema M, Mandigers C, Cafro AM, Palmas A, Carvalho S, Spencer A, Boccadoro M, Sonneveld P. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020 Jun;7(6):e456-e468. Epub 2020 Apr 30. Erratum in: Lancet Haematol. 2020 Jun;7(6):e443. Erratum in: Lancet Haematol. 2020 Nov;7(11):e785. link to original article EuroPMC NCT01208766
## Update: Sonneveld P, Dimopoulos MA, Beksac M, van der Holt B, Aquino S, Ludwig H, Zweegman S, Zander T, Zamagni E, Wester R, Hajek R, Pantani L, Dozza L, Gay F, Cafro A, De Rosa L, Morelli A, Gregersen H, Gulbrandsen N, Cornelisse P, Troia R, Oliva S, van de Velden V, Wu K, Ypma PF, Bos G, Levin MD, Pour L, Driessen C, Broijl A, Croockewit A, Minnema MC, Waage A, Hveding C, van de Donk NWCJ, Offidani M, Palumbo GA, Spencer A, Boccadoro M, Cavo M. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Nov 10;39(32):3613-3622. Epub 2021 Sep 14. link to original article EuroPMC
=Maintenance after first-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Alexanian et al. 1975 	1965-1972 	Phase 3 (C)	1. MP2. Carmustine & Prednisone	Did not meet efficacy endpoints
Belch et al. 1988 	1977-1984 	Phase 3 (C)	MP 	Shorter FFS
Mandelli et al. 1990 	1985-1988 	Phase 3 (C)	IFN alfa-2b 	Might have shorter OS
Salmon et al. 1994 (SWOG S8624) 	1985-1990 	Phase 3 (C)	IFN alfa 	Did not meet primary endpoint of RFS
Browman et al. 1995 	1987-1992 	Phase 3 (C)	IFN alfa-2b 	Seems to have shorter OS
Schaar et al. 2005 (HOVON-16) 	1991-1997 	Phase 3 (C)	IFN alfa-2b 	Shorter PFS
Attal et al. 2006 (IFM 99-02) 	2000-2003 	Phase 3 (C)	1. Thalidomide 	Shorter OS
Attal et al. 2006 (IFM 99-02) 	2000-2003 	Phase 3 (C)	2. Pamidronate 	Did not meet endpoint of OS
Stewart et al. 2013 (NCIC-CTG MY.10) 	2002-2009 	Phase 3 (C)	TP 	Did not meet primary endpoint of OSOS48: 60% vs 68%(HR 1.30)
Morgan et al. 2010 (MRC Myeloma IX) 	2003-2007 	Phase 3 (C)	Thalidomide 	Shorter PFS
Mellqvist et al. 2013 (NMSG 15/05) 	2005-2009 	Phase 3 (C)	Bortezomib 	Might have shorter PFS
Palumbo et al. 2014 (MPRvsMEL200) 	2007-2009 	Phase 3 (C)	Lenalidomide 	Shorter PFS
Jackson et al. 2018 (UK NCRI Myeloma XI)	2011-01-13 to 2017-08-11	Phase 3 (C)	1. Lenalidomide 	Shorter PFS
Jackson et al. 2018 (UK NCRI Myeloma XI)	2011-01-13 to 2017-08-11	Phase 3 (C)	2. Lenalidomide & Vorinostat 	Not reported
No further treatment; used as a comparator arm.
====Preceding treatment====
*Mandelli et al. 1990: Induction MP x 12 mo or VMCP/VBAP x 12 mo
*Browman et al. 1995 & HOVON-16: Induction MP
*IFM 99-02: Induction VAD x 3 to 4, then MEL140 & MEL200 tandem auto HSCT
===References===
# Alexanian R, Balcerzak SP, Haut A, Hewlett J, Gehan E. Remission maintenance therapy for multiple myeloma. Arch Intern Med. 1975 Jan;135(1):147-52. link to original article EuroPMC
# Belch A, Shelley W, Bergsagel D, Wilson K, Klimo P, White D, Willan A. A randomized trial of maintenance versus no maintenance melphalan and prednisone in responding multiple myeloma patients. Br J Cancer. 1988 Jan;57(1):94-9. link to original article link to original article EuroPMC
# Mandelli F, Avvisati G, Amadori S, Boccadoro M, Gernone A, Lauta VM, Marmont F, Petrucci MT, Tribalto M, Vegna ML, Dammacco F, Pileri A. Maintenance treatment with recombinant interferon alfa-2b in patients with multiple myeloma responding to conventional induction chemotherapy. N Engl J Med. 1990 May 17;322(20):1430-4. link to original article EuroPMC
# SWOG S8624: Salmon SE, Crowley JJ, Grogan TM, Finley P, Pugh RP, Barlogie B. Combination chemotherapy, glucocorticoids, and interferon alfa in the treatment of multiple myeloma: a Southwest Oncology Group study. J Clin Oncol. 1994 Nov;12(11):2405-14. link to original article EuroPMC
# Browman GP, Bergsagel D, Sicheri D, O'Reilly S, Wilson KS, Rubin S, Belch A, Shustik C, Barr R, Walker I, James K, Zee B, Johnston D; National Cancer Institute of Canada Clinical Trials Group. Randomized trial of interferon maintenance in multiple myeloma: a study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1995 Sep;13(9):2354-60. link to original article EuroPMC
# HOVON-16: Schaar CG, Kluin-Nelemans HC, Te Marvelde C, le Cessie S, Breed WP, Fibbe WE, van Deijk WA, Fickers MM, Roozendaal KJ, Wijermans PW; HOVON. Interferon-alpha as maintenance therapy in patients with multiple myeloma. Ann Oncol. 2005 Apr;16(4):634-9. Epub 2005 Mar 1. link to original article EuroPMC
# IFM 99-02: Attal M, Harousseau JL, Leyvraz S, Doyen C, Hulin C, Benboubker L, Yakoub Agha I, Bourhis JH, Garderet L, Pegourie B, Dumontet C, Renaud M, Voillat L, Berthou C, Marit G, Monconduit M, Caillot D, Grobois B, Avet-Loiseau H, Moreau P, Facon T; IFM. Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood. 2006 Nov 15;108(10):3289-94. Epub 2006 Jul 27. link to original article EuroPMC NCT00222053
## Pooled update: Barlogie B, Attal M, Crowley J, van Rhee F, Szymonifka J, Moreau P, Durie BG, Harousseau JL. Long-term follow-up of autotransplantation trials for multiple myeloma: update of protocols conducted by the Intergroupe Francophone du Myelome, Southwest Oncology Group, and University of Arkansas for Medical Sciences. J Clin Oncol. 2010 Mar 1;28(7):1209-14. Epub 2010 Jan 19. Erratum in: J Clin Oncol. 2010 Jul 20;28(21):3543. link to original article link to PMC article EuroPMC
# MRC Myeloma IX: Morgan GJ, Davies FE, Gregory WM, Cocks K, Bell SE, Szubert AJ, Navarro-Coy N, Drayson MT, Owen RG, Feyler S, Ashcroft AJ, Ross F, Byrne J, Roddie H, Rudin C, Cook G, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Study Group. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Lancet. 2010 Dec 11;376(9757):1989-99. Epub 2010 Dec 3. link to original article link to PMC article EuroPMC ISRCTN68454111
## Update: Morgan GJ, Davies FE, Gregory WM, Russell NH, Bell SE, Szubert AJ, Navarro Coy N, Cook G, Feyler S, Byrne JL, Roddie H, Rudin C, Drayson MT, Owen RG, Ross FM, Jackson GH, Child JA; NCRI Haematological Oncology Study Group. Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. Blood. 2011 Aug 4;118(5):1231-8. Epub 2011 Jun 7. link to original article link to PMC article EuroPMC
## Update: Morgan GJ, Gregory WM, Davies FE, Bell SE, Szubert AJ, Brown JM, Coy NN, Cook G, Russell NH, Rudin C, Roddie H, Drayson MT, Owen RG, Ross FM, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Studies Group. The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis. Blood. 2012 Jan 5;119(1):7-15. Epub 2011 Oct 20. link to original article EuroPMC
## Update: Morgan GJ, Davies FE, Gregory WM, Bell SE, Szubert AJ, Navarro Coy N, Cook G, Feyler S, Johnson PR, Rudin C, Drayson MT, Owen RG, Ross FM, Russell NH, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Studies Group. Cyclophosphamide, thalidomide, and dexamethasone as induction therapy for newly diagnosed multiple myeloma patients destined for autologous stem-cell transplantation: MRC Myeloma IX randomized trial results. Haematologica. 2012 Mar;97(3):442-50. Epub 2011 Nov 4. link to original article link to PMC article EuroPMC
## Update: Morgan GJ, Davies FE, Gregory WM, Bell SE, Szubert AJ, Cook G, Drayson MT, Owen RG, Ross FM, Jackson G, Child JA. Long-term follow-up of MRC Myeloma IX trial: Survival outcomes with bisphosphonate and thalidomide treatment. Clin Cancer Res. 2013 Nov 1;19(21):6030-8. Epub 2013 Aug 30. link to original article EuroPMC
# BMT CTN 0102: Krishnan A, Pasquini MC, Logan B, Stadtmauer EA, Vesole DH, Alyea E 3rd, Antin JH, Comenzo R, Goodman S, Hari P, Laport G, Qazilbash MH, Rowley S, Sahebi F, Somlo G, Vogl DT, Weisdorf D, Ewell M, Wu J, Geller NL, Horowitz MM, Giralt S, Maloney DG; BMT CTN. Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial. Lancet Oncol. 2011 Dec;12(13):1195-203. Epub 2011 Sep 29. link to original article link to PMC article EuroPMC NCT00075829
# NCIC-CTG MY.10: Stewart AK, Trudel S, Bahlis NJ, White D, Sabry W, Belch A, Reiman T, Roy J, Shustik C, Kovacs MJ, Rubinger M, Cantin G, Song K, Tompkins KA, Marcellus DC, Lacy MQ, Sussman J, Reece D, Brundage M, Harnett EL, Shepherd L, Chapman JA, Meyer RM. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial. Blood. 2013 Feb 28;121(9):1517-23. Epub 2013 Jan 7. link to original article link to PMC article EuroPMC NCT00049673
# NMSG 15/05: Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, Steingrimsdottir H, Abildgaard N, Ahlberg L, Blimark C, Dahl IM, Forsberg K, Gedde-Dahl T, Gregersen H, Gruber A, Guldbrandsen N, Haukås E, Carlson K, Kvam AK, Nahi H, Lindås R, Andersen NF, Turesson I, Waage A, Westin J; Nordic Myeloma Study Group. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial. Blood. 2013 Jun 6;121(23):4647-54. Epub 2013 Apr 24. link to original article link to PMC article EuroPMC NCT00417911
# MPRvsMEL200: Palumbo A, Cavallo F, Gay F, Di Raimondo F, Ben Yehuda D, Petrucci MT, Pezzatti S, Caravita T, Cerrato C, Ribakovsky E, Genuardi M, Cafro A, Marcatti M, Catalano L, Offidani M, Carella AM, Zamagni E, Patriarca F, Musto P, Evangelista A, Ciccone G, Omedé P, Crippa C, Corradini P, Nagler A, Boccadoro M, Cavo M. Autologous transplantation and maintenance therapy in multiple myeloma. N Engl J Med. 2014 Sep 4;371(10):895-905. link to original article EuroPMC NCT00551928
# UK NCRI Myeloma XI: Jackson GH, Davies FE, Pawlyn C, Cairns DA, Striha A, Collett C, Hockaday A, Jones JR, Kishore B, Garg M, Williams CD, Karunanithi K, Lindsay J, Jenner MW, Cook G, Russell NH, Kaiser MF, Drayson MT, Owen RG, Gregory WM, Morgan GJ; UK NCRI Haemato-oncology Clinical Studies Group. Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):57-73. Epub 2018 Dec 14. link to original article link to PMC article EuroPMC NCT01554852
##Update: Jackson GH, Davies FE, Pawlyn C, Cairns DA, Striha A, Collett C, Waterhouse A, Jones JR, Kishore B, Garg M, Williams CD, Karunanithi K, Lindsay J, Allotey D, Shafeek S, Jenner MW, Cook G, Russell NH, Kaiser MF, Drayson MT, Owen RG, Gregory WM, Morgan GJ, Clinical Studies Group UNHO. Lenalidomide before and after autologous stem cell transplantation for transplant-eligible patients of all ages in the randomized, phase III, Myeloma XI trial. Haematologica. 2021 Jul 1;106(7):1957-1967. link to original article link to PMC article EuroPMC
##Update: Jenner MW, Pawlyn C, Davies FE, Menzies T, Hockaday A, Olivier C, Jones JR, Karunanithi K, Lindsay J, Kishore B, Cook G, Drayson MT, Kaiser MF, Owen RG, Gregory W, Cairns DA, Morgan GJ, Jackson GH; UK National Cancer Research Institute (NCRI) Haemato-oncology Clinical Studies Group. The addition of vorinostat to lenalidomide maintenance for patients with newly diagnosed multiple myeloma of all ages: results from 'Myeloma XI', a multicentre, open-label, randomised, phase III trial. Br J Haematol. 2023 Apr;201(2):267-279. Epub 2022 Dec 21. link to original article link to PMC article EuroPMC
# CASSIOPEIA part 2: Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Béné MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuillème S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. Epub 2021 Sep 13. link to original article EuroPMC NCT02541383
##Update: Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Zweegman S, Caillon H, Caillot D, Avet-Loiseau H, Delforge M, Dejoie T, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Schiano de Colella JM, van de Donk NW, Wuillème S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Hua W, Wang J, Tuozzo A, de Boer C, Rowe M, Vanquickelberghe V, Carson R, Vermeulen J, Corre J, Sonneveld P; Intergroupe Francophone du Myélome, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and the CASSIOPEIA Investigators. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024 Aug;25(8):1003-1014. Epub 2024 Jun 15. link to original article EuroPMC
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
McCarthy et al. 2012 (CALGB 100104) 	2005-2009 	Phase 3 (C) 	Lenalidomide	Shorter OS
Attal et al. 2012 (IFM 2005-02) 	2006-2008 	Phase 3 (C) 	Lenalidomide	Shorter PFSMedian PFS: 23 vs 41 mo(HR 2.00)
Palumbo et al. 2012 (MM-015) 	2007-02 to 2008-09 	Phase 3 (E-de-esc)	Lenalidomide	Shorter PFS
Dimopoulos et al. 2018 (TOURMALINE-MM3)	2014-2016 	Phase 3 (C) 	Ixazomib 	Shorter PFSMedian PFS: 21.3 vs 26.5 mo(HR 1.39, 95% CI 1.12-1.72)
No active antineoplastic treatment.
====Preceding treatment====
*MM-015: MPR induction x 9
===References===
# IFM 2005-02: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. link to original article EuroPMC NCT00430365
## Update: Abstract: Michel Attal, MD, Valerie Cances Lauwers, Gerald Marit, Denis Caillot, Thierry Facon, MD, Cyrille Hulin, Philippe Moreau, MD, Claire Mathiot, Murielle Roussel, Catherine Payen, H. Avet-Loiseau and Jean Luc Harousseau. Maintenance Treatment with Lenalidomide After Transplantation for MYELOMA : Final Analysis of the IFM 2005-02. ASH 2010 Abstract 310.
# MM-015: Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, Gisslinger H, Wiktor-Jedrzejczak W, Zodelava M, Weisel K, Cascavilla N, Iosava G, Cavo M, Kloczko J, Bladé J, Beksac M, Spicka I, Plesner T, Radke J, Langer C, Ben Yehuda D, Corso A, Herbein L, Yu Z, Mei J, Jacques C, Dimopoulos MA; MM-015 Investigators. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012 May 10;366(19):1759-69. Erratum in: N Engl J Med. 2012 Jul 19;367(3):285. link to original article EuroPMC NCT00405756
# CALGB 100104: McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, Van Besien K, Gentile T, Isola L, Maziarz RT, Gabriel DA, Bashey A, Landau H, Martin T, Qazilbash MH, Levitan D, McClune B, Schlossman R, Hars V, Postiglione J, Jiang C, Bennett E, Barry S, Bressler L, Kelly M, Seiler M, Rosenbaum C, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Anderson KC, Linker C. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1770-81. link to original article link to supplementary appendix link to PMC article EuroPMC NCT00114101
## Update: Holstein SA, Jung SH, Richardson PG, Hofmeister CC, Hurd DD, Hassoun H, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, van Besien K, Gentile TG, Isola L, Maziarz RT, Bashey A, Landau H, Martin T, Qazilbash MH, Rodriguez C, McClune B, Schlossman RL, Smith SE, Hars V, Owzar K, Jiang C, Boyd M, Schultz C, Wilson M, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Linker C, Anderson KC, McCarthy PL. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol. 2017 Sep;4(9):e431-e442. Epub 2017 Aug 17. link to original article link to PMC article EuroPMC
# TOURMALINE-MM3: Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. Epub 2018 Dec 10. link to original article EuroPMC NCT02181413
=Relapsed or refractory=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Holland et al. 1966	1958-1961 	Randomized (C)	Urethane 	Seems to have longer OS
No active antineoplastic treatment.
===References===
# Holland JF, Hosley H, Scharlau C, Carbone PP, Frei E 3rd, Brindley CO, Hall TC, Shnider BI, Gold GL, Lasagna L, Owens AH Jr, Miller SP. A controlled trial of urethane treatment in multiple myeloma. Blood. 1966 Mar;27(3):328-42. link to original article EuroPMC
=Consolidation after second-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Cook et al. 2024 (ACCoRD)	2017-12-12 to 2023-04-21	Phase 3 (C)	ITd 	Shorter PFSMedian PFS: 13 vs 20 mo(HR 1.82, 95% CI 1.28-2.56)
No further treatment.
====Preceding treatment====
*Salvage autologous HSCT
===References===
#ACCoRD: Cook G, Ashcroft AJ, Senior E, Olivier C, Hockaday A, Richards J, Cavenagh JD, Snowden JA, Drayson MT, de Tute R, Roberts L, Owen RG, Yong K, Garg M, Boyd K, Sati H, Gillson S, Cook M, Cairns DA, Parrish C; United Kingdom Myeloma Research Alliance. Ixazomib as consolidation and maintenance versus observation in patients with relapsed multiple myeloma eligible for salvage autologous stem-cell transplantation (Myeloma XII [ACCoRD]): interim analysis of a multicentre, open-label, randomised, phase 3 trial. Lancet Haematol. 2024 Nov;11(11):e816-e829. Epub 2024 Sep 6. link to original article EuroPMC ISRCTN10038996
Category:Multiple myeloma regimens
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Category:Null regimens