Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone

被引:20
作者
Morgan, Gareth [1 ]
Palumbo, Antonio [2 ]
Dhanasiri, Sujith [3 ]
Lee, Dawn [4 ]
Weisel, Katja [5 ]
Facon, Thierry [6 ]
Delforge, Michel [7 ]
Oriol, Albert [8 ]
Zaki, Mohamed [9 ]
Yu, Xin [9 ]
Sternas, Lars [9 ]
Jacques, Christian [9 ]
Akehurst, Ron [4 ,10 ]
Offner, Fritz [11 ]
Dimopoulos, Meletios A. [12 ]
机构
[1] Univ Arkansas Med Sci, Myeloma Inst Res & Therapy, Little Rock, AR 72205 USA
[2] Via Univ Torino, Turin, Italy
[3] Celgene Ltd, London, England
[4] Bres Med, Sheffield, S Yorkshire, England
[5] Univ Tubingen, Tubingen, Germany
[6] CHU Lille, Serv Malad Sang, F-59037 Lille, France
[7] Univ Hosp Leuven, Leuven, Belgium
[8] Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
[9] Celgene Corp, Summit, NJ USA
[10] Univ Sheffield, Sheffield, S Yorkshire, England
[11] Univ Ziekenhuis Gent, Ghent, Belgium
[12] Univ Athens, Alexandra Hosp, Sch Med, Athens 11528, Greece
关键词
multiple myeloma; pomalidomide; survival; crossover; bias;
D O I
10.1111/bjh.13227
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 70months (127 vs. 57months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.
引用
收藏
页码:820 / 823
页数:4
相关论文
共 12 条
  • [1] [Anonymous], 2012, Health Outcome Res Med, DOI DOI 10.1016/J.EHRM.2012.01.001
  • [2] Double Refractory Myeloma: Analysis Of Clinical Outcomes and Medical-Resource Utilisation In a Single Centre
    Gooding, Sarah
    Lau, I-Jun
    Sheikh, Mimi
    Roberts, Pamela
    Wong, Julia
    Dickens, Emmy
    Elvidge, Jamie
    Lee, Dawn
    Ramasamy, Karthik
    [J]. BLOOD, 2013, 122 (21)
  • [3] Adjusting for Patient Crossover in Clinical Trials Using External Data: A Case Study of Lenalidomide for Advanced Multiple Myeloma
    Ishak, K. Jack
    Caro, J. Jaime
    Drayson, Mark T.
    Dimopoulos, Meletios
    Weber, Donna
    Augustson, Bradley
    Child, J. Anthony
    Knight, Robert
    Iqbal, Gulnaz
    Dunn, Janet
    Shearer, Arran
    Morgan, Gareth
    [J]. VALUE IN HEALTH, 2011, 14 (05) : 672 - 678
  • [4] Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: A multicenter international myeloma working group study
    Kumar, S. K.
    Lee, J. H.
    Lahuerta, J. J.
    Morgan, G.
    Richardson, P. G.
    Crowley, J.
    Haessler, J.
    Feather, J.
    Hoering, A.
    Moreau, P.
    LeLeu, X.
    Hulin, C.
    Klein, S. K.
    Sonneveld, P.
    Siegel, D.
    Blade, J.
    Goldschmidt, H.
    Jagannath, S.
    Miguel, J. S.
    Orlowski, R.
    Palumbo, A.
    Sezer, O.
    Rajkumar, S. V.
    Durie, B. G. M.
    [J]. LEUKEMIA, 2012, 26 (01) : 149 - 157
  • [5] Clinical course of patients with relapsed multiple myeloma
    Kumar, SK
    Therneau, TM
    Gertz, MA
    Lacy, MQ
    Dispenzieri, A
    Rajkumar, SV
    Fonseca, R
    Witzig, TE
    Lust, JA
    Larson, DR
    Kyle, RA
    Greipp, PR
    [J]. MAYO CLINIC PROCEEDINGS, 2004, 79 (07) : 867 - 874
  • [6] Latimer N. R., 2013, 1306 HEDS
  • [7] Maciorowski G., 2014, SPOTTED EAGLE VANISH
  • [8] Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study
    Morden, James P.
    Lambert, Paul C.
    Latimer, Nicholas
    Abrams, Keith R.
    Wailoo, Allan J.
    [J]. BMC MEDICAL RESEARCH METHODOLOGY, 2011, 11
  • [9] Pomalidomide plus low-dose dexamethasone (POM plus LoDEX) versus high-dose dexamethasone (HiDEX) for relapsed or refractory multiple myeloma (RRMM): Overall survival (OS) results of MM-003 after adjustment for Res crossover.
    Morgan, Gareth J.
    San Miguel, Jesus
    Dhanasiri, Sujith
    Lee, Dawn
    Palumbo, Antonio
    Facon, Thierry
    Zaki, Mohamed H.
    Yu, Xin
    Sternas, Lars Axel
    Jacques, Christian
    Weisel, Katja C.
    Offner, Fritz
    Dimopoulos, Meletios A.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (15)
  • [10] Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial
    San Miguel, Jesus
    Weisel, Katja
    Moreau, Philippe
    Lacy, Martha
    Song, Kevin
    Delforge, Michel
    Karlin, Lionel
    Goldschmidt, Hartmut
    Banos, Anne
    Oriol, Albert
    Alegre, Adrian
    Chen, Christine
    Cavo, Michele
    Garderet, Laurent
    Ivanova, Valentina
    Martinez-Lopez, Joaquin
    Belch, Andrew
    Palumbo, Antonio
    Schey, Stephen
    Sonneveld, Pieter
    Yu, Xin
    Sternas, Lars
    Jacques, Christian
    Zaki, Mohamed
    Dimopoulos, Meletios
    [J]. LANCET ONCOLOGY, 2013, 14 (11) : 1055 - 1066