Bologna96.

Methods	Central randomisation before induction treatment Multicentre (N=32) RCT addressing superiority of TASCT
Participants	TASCT N=158, SASCT N=163 age < 60 years Previously untreated, symptomatic or progressive MM Salmon‐Durie stage I‐III (Baseline characteristics Table 2)
Interventions	1x 200 mg/m² melphalan + (140 mg/m² melphalan + 12 mg/m² oral busulfan) vs 1 x 200 mg/m² melphalan SASCT (Treatment regimen Table 3)
Outcomes	OS, EFS, transplantation‐related mortality in ITT population (Definition of endpoints Table 4; Table 5)
Period and Location	Jan 96 – Dec 01 in Italy
Sample size calculation	Improvement of CR/nCR
ITT analysis (n of drop‐outs)	Yes (N=3/321 in SASCT)
Notes	Journal publication (peer‐review) Null‐bias (only 65% compliance with 2nd ASCT) Potential confounding by subsequent treatment (superior post‐relapse survival for SASCT arm)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central
Allocation concealment (selection bias)	Unclear risk	Central
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