Table 1

Thalidomide maintenance studies after ASCT and conventional therapy

Study groupMedian age, y (no. of patients)Induction therapyMaintenance dose, duration of treatmentImprovement in quality of responseEFS or PFS*OS*Survival after relapseThalidomide tolerance
IFM 99-02: Attal et al15  (2006) Mean 59 ± 8 (N = 597) VAD: 3 or 4 cycles, Single ASCT (A) Thalidomide 400 mg/d until PD VGPR: (A) 67% 3-y EFS: (A) 52% 4-y OS: (A) 87% 1-y OS: (A) 75% 39% stopped thalidomide because of side effects, mostly PNP, all grades of PNP 68%, grades 3 or 4: 7% 
    Pamidronate 90 mg, every 4 wks, until PD     
(B) Pamidronate 90 mg, every 4 wks, until PD (B) 55% (B) 37% (B) 74% (B) 73% 
(C) None (C) 57% (C) 36% (C) 77% (C) 78% 
 P = .03 P < .009 P < .04 P = .7 
ALLG MM6: Spencer et al16  (2009) ≤ 70 (N = 243) Mostly VAD Single ASCT (A) Thalidomide 100-200 mg/d, for 12 mo VGPR: (A) 65% 3-y PFS estimate: (A) 42% 3-y OS estimate: (A) 86% 1-y OS estimate: (A) 79% 30% stopped therapy because of intolerance (mostly PNP), 10% grades 3 or 4 PNP and 9% stopped because of PD 
    Prednisolone 50 mg on alternate days until PD     
(B) Prednisolone 50 mg on alternate days until PD (B) 44% (B) 23% (B) 75% (B) 77% 
P = .001 P < .001 P = .004 P = .237 
MRC Myeloma IX: Morgan et al17  (2012) Intensive, 59 (N = 493) CVAD vs CTD, single ASCT (A) Thalidomide, 50-100 mg/day, until PD† No difference in the percentage of patients that upgraded response status P = .19 PFS: (A) 30 mo 3-year OS: (A) 75% (A) 20 mo 52.2% discontinued maintenance before PD mainly because of adverse events, median duration of treatment: 7 mo‡ 
(B) None† (B) 27 mo P = .003 (B) 80% P = .26 (B) 36 mo P = .003 
Nonintensive, 73 (N = 327) CTD attenuated vs MP (A) Thalidomide, 50-100 mg/day, until PD† PFS: (A) 11 mo (A) 38 mo (A) 21 mo 
(B) None† (B) 9 mo P = .014 (B) 39 mo P = .995 (B) 26 mo P = .25 
TT2: Barlogie et al18  (2006) ≤ 75, median NA (N = 668) Median follow-up: 42 mo (A) 4 induction cycles, double ASCT 4 consolidation cycles, thalidomide 400 mg/d during induction, 100 mg between ASCT, 200 mg with consolidation (A) Thalidomide 100 mg during the first year, thereafter 50 mg on alternate days, until PD CR: (A) 62% 4-y EFS: A) 65% OS: A) Not stated Median OS: A) 1.1 y 30% stopped thalidomide within 2 y 
 (B) Same induction without thalidomide (B) None (B) 43% P = .001 (B) 44% P = .01 (B) Not stated P = .9 (B) 2.7 y P = .001  
TT2: Barlogie et al19  (2008) Median follow-up: 70 mo   CR: (A) 64%† EFS median: (A) 6.0 y 8-y OS estimate: (A) 57% 5-y OS estimate: (A) 27% ∼ 80% stopped thalidomide because of toxicity within 2 y† 
  (B) 43% (B) 4.1 y (B) 44% (B) 23% 
    P = .001 P = .001 P = .09 P = .11  
TT2: Barlogie et al20  (2010) Median follow-up: 87 mo (N = 668)   NA EFS median: 4.8 y OS median 9 y 7.2 y OS estimate: NA 
(A) 45.2% 
(B) 42.2% 
P = .27 
HOVON 50: Lokhorst et al21  (2008) 56 (N = 556) VAD vs TAD Single or double ASCT (A) Thalidomide, 50 mg/d, until PD VGPR: EFS: Median: Median OS: PNP grades 2-4: ∼ 50% Treatment discontinued or dose reduced: 58% 
(A) 66% (A) 34 mo (A) 73 mo (A) 20 mo 
 (B) 22 mo, P < .001   
(B) IFN-α, 3 MU, 3 times weekly, until PD (B) 54% PFS: (B) 60 mo (B) 31 mo 
P = .005 (A) 34 mo P = .77 P = .009 
 (B) 25 mo P < .001   
NCIC CTG MY10: Stewart et al22  (2010) 58 (N = 332) Induction therapy not specified Single ASCT (A) Thalidomide 200 mg/d and alternate-day prednisone 50 mg, until PD  PFS: (A) 28 mo 4-y OS estimate: (A) 68%  Increased toxicity, including PNP and reduced quality of life, improved appetite, and sleep VTE: 7% 
(B) None  (B) 17 mo (B) 60%  VTE: 0% 
     P < .0001 P = .21   
CEMSG: Ludwig et al25  (2010) 72 (N = 124) Thalidomide/dexamethasone vs MP (A) Thalidomide 200 mg up to maximum tolerated dose, until PD IFN-α-2b, 3 MU, 3 times weekly (A) PR to VGPR or CR: 8% PFS: (A) 27.7 mo (A) 52.6 mo OS after PD: (A) 8.1 mo PNP grades 3 or 4: 11% 
   (B) IFN-α-2b, 3 MU, 3 times weekly (B) PR to VGPR or CR: 2% (B) 13.2 mo P = .0068 (B) 51.4 mo P = .81 (B) 25.5 mo P = .056  
Study groupMedian age, y (no. of patients)Induction therapyMaintenance dose, duration of treatmentImprovement in quality of responseEFS or PFS*OS*Survival after relapseThalidomide tolerance
IFM 99-02: Attal et al15  (2006) Mean 59 ± 8 (N = 597) VAD: 3 or 4 cycles, Single ASCT (A) Thalidomide 400 mg/d until PD VGPR: (A) 67% 3-y EFS: (A) 52% 4-y OS: (A) 87% 1-y OS: (A) 75% 39% stopped thalidomide because of side effects, mostly PNP, all grades of PNP 68%, grades 3 or 4: 7% 
    Pamidronate 90 mg, every 4 wks, until PD     
(B) Pamidronate 90 mg, every 4 wks, until PD (B) 55% (B) 37% (B) 74% (B) 73% 
(C) None (C) 57% (C) 36% (C) 77% (C) 78% 
 P = .03 P < .009 P < .04 P = .7 
ALLG MM6: Spencer et al16  (2009) ≤ 70 (N = 243) Mostly VAD Single ASCT (A) Thalidomide 100-200 mg/d, for 12 mo VGPR: (A) 65% 3-y PFS estimate: (A) 42% 3-y OS estimate: (A) 86% 1-y OS estimate: (A) 79% 30% stopped therapy because of intolerance (mostly PNP), 10% grades 3 or 4 PNP and 9% stopped because of PD 
    Prednisolone 50 mg on alternate days until PD     
(B) Prednisolone 50 mg on alternate days until PD (B) 44% (B) 23% (B) 75% (B) 77% 
P = .001 P < .001 P = .004 P = .237 
MRC Myeloma IX: Morgan et al17  (2012) Intensive, 59 (N = 493) CVAD vs CTD, single ASCT (A) Thalidomide, 50-100 mg/day, until PD† No difference in the percentage of patients that upgraded response status P = .19 PFS: (A) 30 mo 3-year OS: (A) 75% (A) 20 mo 52.2% discontinued maintenance before PD mainly because of adverse events, median duration of treatment: 7 mo‡ 
(B) None† (B) 27 mo P = .003 (B) 80% P = .26 (B) 36 mo P = .003 
Nonintensive, 73 (N = 327) CTD attenuated vs MP (A) Thalidomide, 50-100 mg/day, until PD† PFS: (A) 11 mo (A) 38 mo (A) 21 mo 
(B) None† (B) 9 mo P = .014 (B) 39 mo P = .995 (B) 26 mo P = .25 
TT2: Barlogie et al18  (2006) ≤ 75, median NA (N = 668) Median follow-up: 42 mo (A) 4 induction cycles, double ASCT 4 consolidation cycles, thalidomide 400 mg/d during induction, 100 mg between ASCT, 200 mg with consolidation (A) Thalidomide 100 mg during the first year, thereafter 50 mg on alternate days, until PD CR: (A) 62% 4-y EFS: A) 65% OS: A) Not stated Median OS: A) 1.1 y 30% stopped thalidomide within 2 y 
 (B) Same induction without thalidomide (B) None (B) 43% P = .001 (B) 44% P = .01 (B) Not stated P = .9 (B) 2.7 y P = .001  
TT2: Barlogie et al19  (2008) Median follow-up: 70 mo   CR: (A) 64%† EFS median: (A) 6.0 y 8-y OS estimate: (A) 57% 5-y OS estimate: (A) 27% ∼ 80% stopped thalidomide because of toxicity within 2 y† 
  (B) 43% (B) 4.1 y (B) 44% (B) 23% 
    P = .001 P = .001 P = .09 P = .11  
TT2: Barlogie et al20  (2010) Median follow-up: 87 mo (N = 668)   NA EFS median: 4.8 y OS median 9 y 7.2 y OS estimate: NA 
(A) 45.2% 
(B) 42.2% 
P = .27 
HOVON 50: Lokhorst et al21  (2008) 56 (N = 556) VAD vs TAD Single or double ASCT (A) Thalidomide, 50 mg/d, until PD VGPR: EFS: Median: Median OS: PNP grades 2-4: ∼ 50% Treatment discontinued or dose reduced: 58% 
(A) 66% (A) 34 mo (A) 73 mo (A) 20 mo 
 (B) 22 mo, P < .001   
(B) IFN-α, 3 MU, 3 times weekly, until PD (B) 54% PFS: (B) 60 mo (B) 31 mo 
P = .005 (A) 34 mo P = .77 P = .009 
 (B) 25 mo P < .001   
NCIC CTG MY10: Stewart et al22  (2010) 58 (N = 332) Induction therapy not specified Single ASCT (A) Thalidomide 200 mg/d and alternate-day prednisone 50 mg, until PD  PFS: (A) 28 mo 4-y OS estimate: (A) 68%  Increased toxicity, including PNP and reduced quality of life, improved appetite, and sleep VTE: 7% 
(B) None  (B) 17 mo (B) 60%  VTE: 0% 
     P < .0001 P = .21   
CEMSG: Ludwig et al25  (2010) 72 (N = 124) Thalidomide/dexamethasone vs MP (A) Thalidomide 200 mg up to maximum tolerated dose, until PD IFN-α-2b, 3 MU, 3 times weekly (A) PR to VGPR or CR: 8% PFS: (A) 27.7 mo (A) 52.6 mo OS after PD: (A) 8.1 mo PNP grades 3 or 4: 11% 
   (B) IFN-α-2b, 3 MU, 3 times weekly (B) PR to VGPR or CR: 2% (B) 13.2 mo P = .0068 (B) 51.4 mo P = .81 (B) 25.5 mo P = .056  
*

Data are median values unless otherwise stated.

†

Same regimen for intensive and nonintensive patients.

‡

Results for intensive and nonintensive group combined.

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