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 |
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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) |
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Interventions | 2 x 200 mg/m² melphalan TASCT compared to experimental SASCT (chemo‐radio conditioning regimen) (Treatment plan Table 3) |
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Outcomes | OS, EFS (primary endpoint), so‐called TRM (Definitions of endpoints Table 4; Table 5) |
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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 |
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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 |