2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

MAINTENANCE THERAPY FOR MULTIPLE MYELOMA
Trial
Author and Year
Table 1. IMiDs Thalidomide and Lenalidomide Maintenance Studies after ASCT and Conventional Chemotherapy
n
Age Maintenance Dose Comparator
Duration of
Maintenance PFS/EFS OS Survival after Relapse
Thalidomide Trials
Post ASCT Thal� Thal� Thal� Thal� Thal� Thal�
IFM 95–02 597 Thalidomide Pamidronate or Until progression 52%*
37%* 87%*
75%* 75% 75%
200–400 mg/d Observation
(3-yr from
(4-yr from
(1-yr OS)
Attal et al 2006 � 65 y � Pamidronate
randomization)
enrollment)
Total therapy 2 668 Thalidomide IFN Until progression 56%* 44% Not reached 7 yr 27% 23%
100 mg/d
1st year
then 50 mg
alternate days
(5-yr)
(median, yr)
(5-yr OS)
Barlogie et al
2006–2008
� 75 y � IFN
ALLG MM6 243 Thalidomide
100–200 mg/d
Spencer et al 2009 � 70 y � Prednisolone
NCIC CTG MY.10 332 Thalidomide
200 mg/d
Stewart et al 2010 � 65 y �prednisone
Prednisolone 12 mo
(prednisolone
until progression)
Observation 48 mo or until
progression
42%*
(3-yr PFS)
28 mo*
(median, mo)
23%* 86%*
(3-yr OS)
17 mo NR
(median, yr)
75%* 79%
(1-yr OS)
5 y N/A
HOVON-50 556 Thalidomide IFN Until progression 34 mo* 25 mo* 73 mo 60 mo 20 mo* 31 mo*
Lokhorst et al 2010 � 65 y 50 mg/d (median, mo) (median, mo) (median, mo)
MRC myeloma IX
Morgan et al
2012
493 Thalidomide Observation Until progression 30 mo* 27 mo* 75% 80% 20 mo* 36 mo*
� 65 y 50–100 mg/d (median, mo) (3-yr OS) (median, mo)
Post Chemotherapy Thal� Thal� Thal� Thal� Thal� Thal�
GIMEMA 331 MPT� Thalidomide
100 mg/d
Palumbo et al
2008
� 65 y
MP �
observation
Until progression 22 mo*
(median, mo)
14.5 mo* 45 mo
(median, mo)
77%
48 mo 11.5 mo* 24 mo*
HOVON 49 333 MPT� MP �
Until progression 34%* 14%* 40 mo* 31 mo* N/A
Wijermans et al � 65 y Thalidomide observation
(2-yr PFS)
(median, mo)
2010
50 mg/d
NMSG 357 MPT � MP � Until progression 15 mo 14 mo 29 mo 32 mo N/A
Waage et al 2010 � 65 y Thalidomide
200 mg/j
placebo (median, mo) (median, mo)
CEMSG 128 Thalidomide
200 mg/d
Ludwig et al 2010 � 65 y � IFN
MRC myeloma IX
Morgan et al
2012
IFN Until progression 28 mo*
(median, mo)
13 mo* 53 mo
(median, mo)
51 mo 8 mo
(median, mo)
25 mo
327 Thalidomide Observation Until progression 11 mo* 9 mo* 38 mo 39 mo 21 mo 26 mo
� 65 y 50–100 mg/d (median, mo) (median, mo) (median, mo)
Post ASCT
Lenalidomide Trials
Len� Len� Len� Len� Len� Len�
IFM 2005–02 614 Lenalidomide placebo Until progression 41 mo* 24 mo* 79% 73% 12 mo 12 mo
Attal et al 2011 �65y 10–15 mg/d
(median, mo) (5-yr OS) (median, mo)
CALBG 100104 568 Lenalidomide placebo Until progression 43 mo* 31 mo* N/A N/A
McCarthy et al �65y 10–15 mg/d
(median, mo) 23 versus
2011
39 deaths*
Post chemotherapy Len� Len� Len� Len� Len� Len�
MM 015 499 MPR� MPR or MP � Until progression 31 mo* 14/13 mo* 73% 65% N/A
Palumbo et al �65 y Lenalidomide observation (median, mo) (3-yr OS)
2011
10md/d 21–28d
Abbreviations: PFS, progression-free survival; EFS, event-free survival; OS, overall survival; y, years; mo, months; N/A, not available.
* Statistically significant.
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