2. Baseline characteristics of patients.
| Baseline characteristics | N |
Age [y] |
β2 micro‐globulin [mg/l] |
Sex [% male] |
Durie Salmon stage n (%) |
Status at Rdx | Prognostic factors reported (n) |
Note |
|
IFM94 TASCT |
200; [203* in LTFU] |
52 ± 6 [mean] |
5±9 | 55 | I: 14 (7) II: 31 (16) III: 155 (78) |
Untreated | Age, Alb, B2M,
BM cyt., Ca, Crea, CRP, DS, Hb, LDH, M protein Sex (12) |
"No significant differences between groups" |
|
SASCT IFM94 |
199 [198* in LTFU for EFS] |
52 ± 6 [mean] |
5±6 | 56 | I: 17 II: 23 III:159 |
|||
|
MAG95 TASCT |
114 | 50
[22‐56] (overall) |
2.8 [0.9‐65] (overall) |
NR | I: NR II: ‐ (12) III: ‐ (85) (overall) |
Newly diagnosed | Age, B2M, DS, M protein (4) |
"No significant differences between groups", not reported per treatment arm |
|
MAG95 SASCT |
113 | |||||||
|
Bologna96 TASCT |
158 | 53± 6 | 4.6±7.8 | 60 | I: 31 (20) II: 29 (18) III: 98 (62) |
Previously untreated | Age; B2M; BM cyt.; CRP; Crea.; DS; Hb; Pt; M protein; Sex (10) |
"No statistically significant differences between groups" |
|
Bologna96 SASCT |
163 | 52± 6 | 4.2±5.2 | 61 | I: 32 (20) II: 23 (14) III: 108 (66) |
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|
GMMG‐HD2 TASCT |
180* | 56 (med.) | 2.8 [med.] |
NR | I: (excl.) II: III: (63% in interim analysis) |
At least SD after induction | Age, Alb, B2M, CRP, Hb, (5) |
Reported factors similar after visual inspection; total number of included patients unclear (N=358‐485); |
|
GMMG‐HD2 SASCT |
178* | 55 (med.) | 2.5 [med.] |
NR | I: (excl.) II: III: (70% in interim analysis) |
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|
DSMM‐I TASCT (immature) |
98 | 54 (30‐60) | [>3.5 g/dl] 31.6% |
63 | I: (excl.) II: 28% III: 72% |
At least SD after induction and sufficient number of stem cells collected | Age, B2M, Crea, DS, LDH, M protein, bone, sex (8) |
"No statistically significant differences between groups" |
|
DSMM‐I SASCT (immature) |
100 | 54 (34‐61) |
[>3.5 g/dl] 29% |
63 | I: (excl.) II: 38% III: 62 % |
rounded figures; Alb: serum albumin; B2M: β2 microglobulin; BM cyt: bone marrow cytosis; Ca: serum calcium; Crea: serum creatinine; CRP: C‐reactive protein; DS: Durie‐Salmon stage; Hb: haemoglobin; LDH: serum lactate dehydrogenase, LTFU: long‐term follow‐up; Pt: platelets; Rdx: randomisation
˜ median OS read of KM curves; * evaluated patients