Table 1

Characteristics of the trials

CharacteristicGIMEMAHOVONIFM-IIFM-IINMSGTMSG
Trial label GIMEMA HOVON49 IFM99–06 IFM01/01 NMSG12 TMSG 
Country Italy The Netherlands/Belgium France France Nordic Turkey 
No. of patients 331 333 321 229 357 114 
Inclusion year 2002-05 2002-07 2000-05 2002-06 2002-07 2006-09 
Age, y > 65 > 65 65-75 > 75 > 65 > 55 
SD stage II, III Ib, II, III II, III, and I high-risk II, III, and I high-risk I-III symptomatic I-III symptomatic 
WHO status 0-4 0-3 0-4 0-4 0-4 0-2 
Placebo No No No Yes Yes No 
Melphalan 4 mg/m2 0.25 mg/kg 0.25 mg/kg 0.20 mg/kg 0.25 mg/kg 9‖mg/m2 
Prednisone days 1-4 days 1-5 days 1-4 days 1-4 days 1-4 days 1-4 
 40 mg/m2 1 mg/kg 2 mg/kg 2 mg/kg 100 mg 60 mg/m2 
 days 1-7 days 1-5 days 1-4 days 1-4 days 1-4 days 1-4 
No. of cycles/interval (weeks) 6/4 8/4 12/6 12/6 Until plateau/6 8/6 
Thalidomide, mg/day 100 200 100-400* 100 200-400 100 
Duration Until relapse 8 cycles 12 cycles 12 cycles Until relapse† 8 cycles 
Crossover to MPT from MP No No No No No 18% 
Second-line thalidomide after relapse, % of MP patients 34‡ 57 38 45 45 7 
CharacteristicGIMEMAHOVONIFM-IIFM-IINMSGTMSG
Trial label GIMEMA HOVON49 IFM99–06 IFM01/01 NMSG12 TMSG 
Country Italy The Netherlands/Belgium France France Nordic Turkey 
No. of patients 331 333 321 229 357 114 
Inclusion year 2002-05 2002-07 2000-05 2002-06 2002-07 2006-09 
Age, y > 65 > 65 65-75 > 75 > 65 > 55 
SD stage II, III Ib, II, III II, III, and I high-risk II, III, and I high-risk I-III symptomatic I-III symptomatic 
WHO status 0-4 0-3 0-4 0-4 0-4 0-2 
Placebo No No No Yes Yes No 
Melphalan 4 mg/m2 0.25 mg/kg 0.25 mg/kg 0.20 mg/kg 0.25 mg/kg 9‖mg/m2 
Prednisone days 1-4 days 1-5 days 1-4 days 1-4 days 1-4 days 1-4 
 40 mg/m2 1 mg/kg 2 mg/kg 2 mg/kg 100 mg 60 mg/m2 
 days 1-7 days 1-5 days 1-4 days 1-4 days 1-4 days 1-4 
No. of cycles/interval (weeks) 6/4 8/4 12/6 12/6 Until plateau/6 8/6 
Thalidomide, mg/day 100 200 100-400* 100 200-400 100 
Duration Until relapse 8 cycles 12 cycles 12 cycles Until relapse† 8 cycles 
Crossover to MPT from MP No No No No No 18% 
Second-line thalidomide after relapse, % of MP patients 34‡ 57 38 45 45 7 

HOVON indicates Hemato-Oncologie voor Volwassenen Nederland.

*

Recommended dose was 200 mg/day with rapid increase if well tolerated, up to maximum 400 mg/day.

†

A total of 200 mg/day from plateau until relapse.

‡

Second-line thalidomide or bortezomib.

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