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. 2012 Oct 17;2012(10):CD004626. doi: 10.1002/14651858.CD004626.pub3

DSMM‐I.

Methods Randomisation of patients with at least stable disease after induction and successful stem‐cell mobilisation
Multicentre (N= 46‐49) RCT addressing superiority of experimental SASCT regimen compared to trial; TASCT
Participants TASCT N=98; SASCT N=100
60 years;
de novo or max. < 6 cycles of "conventional Ctx"
Salmon‐Durie stage II and III
(Baseline characteristics Table 2)
Interventions 2 x 200 mg/m² melphalan TASCT compared to experimental SASCT (chemo‐radio conditioning regimen)
(Treatment plan Table 3)
Outcomes OS, EFS (primary endpoint), so‐called TRM
(Definitions of endpoints Table 4; Table 5)
Period and Location Aug. 98 – Jan. 02 in Germany and Italy (USA?)
Sample size calculation Not reported
ITT analysis (n of drop‐outs) Yes (unclear)
Notes Conference presentations with some inconsistencies
Safety population differs notably from ITT population (TASCT N=118; SASCT N=80)
Data likely immature
Total follow‐up of only 48‐61 months according to Kaplan‐Meier graph (reported as median follow‐up)
Potential confounding by cross‐over from SASCT to TASCT in 18% of patients and by subsequent treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NR
Allocation concealment (selection bias) Unclear risk NR
Blinding (performance bias and detection bias) 
 All outcomes High risk Unavoidable in view of obvious difference in treatment plan
Other bias High risk See Table 6 and Figure 2