3. Treatment regimen in included studies.
| Study | Stem cell mobilisation/ source (type; minimal number per transplant | Induction | Conditioning ASCT | Compliance ASCT | Maintenance [Compliance] | Salvage | Cross‐over (SASCT to TASCT) | Notes |
|
IFM94 TASCT |
G‐CSF for PBSC or BM harvest after induction; (PBSC or BM; 2*106 CD34+/kg) |
3‐4 x VAD |
1. Mel 140 2. Mel 140 + 8 Gy TBI |
1. 88% 2. 78% |
Interferon α; [49%] |
59%, e.g. 21% Thal., 17% SCT |
/ | 2nd rdx BM/PBSC no clinically relevant interaction; different dose intensity up to first ASCT; |
|
IFM94 SASCT |
as TASCT | as TASCT | Mel 140 + 8 Gy TBI | 85% | Interferon α; steroids; [57%] |
68% e.g. 12% Thal., 17% SCT |
NR | |
|
MAG95 TASCT |
CYP, G‐CSF; PBSC (PBSC; NR) |
HD steroids and ? | 1. Mel 140 2. Mel 140 +VP16 +12 Gy TBI |
1st: 100% 2nd: 92% |
NR or none | NR | / | Stem cell collection after high‐dose steroids; clinically relevant interaction between purging and ASCT arm; notably different dose intensity and dose density up to and including first ASCT |
|
MAG95 SASCT |
as TASCT |
HD steroids and 3 x “VAD‐like” |
BCNU +VP16,
+Mel 140 +CYP + 12 Gy TBI |
94% | NR | NR | NR | |
|
Bologna96 TASCT |
CYP G‐CSF (PBSC 2*106 CD34+/kg) |
4 x VAD | 1. Mel 200 2. Mel 120 + oral BU (4 mg/kg d‐5 to d‐3) |
1st: 90% 2nd: 65% [e.g. refused by patient: 7%] |
Interferon α; [55%] |
10% SCT 55% novel agents |
/ | Same dose intensity and density up to and including first ASCT; |
|
Bologna96 SASCT |
as TASCT | as TASCT | Mel 200 |
85% | Interferon α; [77%] |
33% SCT; 50% novel agents |
NR | |
|
GMMG‐HD2 TASCT |
HD CYP/IFO G‐CSF (PBSC; NR; purging optional) |
VID or VAD (up to 6 cycles; until CR or plateau) | 1. Mel 200 2. Mel 200 |
1st: 93%* 2nd: 52% [refused by patient: 28%) |
Interferon α; [NR] |
> 20% salvage SCT; > 40 % novel agents ) |
/ | No interaction reported for optional randomisation VID vs VAD (VAD less toxic) and ASCT; same dose intensity and density up to and including first ASCT |
|
GMMG‐HD2 SASCT |
as TASCT | as TASCT | Mel 200 |
88% | Interferon α; [NR] |
(no info per arm reported | NR | |
|
DSMM‐I TASCT |
IEV + G‐CSF
(PBSC 2*106 CD34+/kg) |
4 x ID | 1. Mel 200 2. Mel 200 |
1st: NR 2nd: NR |
Interferon α; [NR] |
NR | / | Different dose intensity up to and including first ASCT |
|
DSMM‐I SASCT |
as TASCT | as TASCT | BU CYP + 9 Gy TMI | 72% | Interferon α; [NR] |
NR | 18% (time point not reported) | |
| Current standard and reporting recommendations | HD CYP + G‐CSF; unselected graft |
novel agent plus dexamethasone | Mel 200; no TBI |
Consider to increase number of drop‐out for sample size calculation | Report compliance per arm | Report number of patients and outcome per arm | Report number of patients and time point/status at cross‐over per arm; |
BM: bone marrow; BCNU: carmustine; BU: busulfan; CD34: cluster of differentiation (stem cell marker); CR: complete response; CYP: cyclophosphamide; G‐CSF: granulocyte‐colony stimulating factor; Gy: Gray; HD: high‐dose; IFO: ifosfamide; IEV: Ifosfamide, epirubicin, etoposide; ID: idarubicin, dexamethasone; Mel: Melphalan; NR: not reported; PBSC: peripheral blood stem cells; rdx: randomisation; SCT: stem cell transplant; TBI: total body irradiation; TMI: total marrow irradiation; VAD: vincristine, adriamycin, dexamethasone; VID: vincristine, idarubicine, dexamethasone VP16 etoposide * of evaluated patients