Summary of high dose therapy trials in multiple myeloma.
. | . | . | . | . | . | . | . | . | . | . | EFS . | OS . | ||||
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Author . | Randomization . | Regimen* . | SDT Regimen . | HDT Regimen . | Maintenance . | N . | Age . | Median FU / mos . | % CR . | P . | Median Mos. . | % Yr . | EFS p . | Median Mos. . | % Yr. . | OS P . |
Abbreviations: SDT, standard dose therapy; HDT, high-dose therapy; IDT, intermediate-dose therapy; IFN, interferon; TBI, total body irradiation; MEL, melphalan; OS, overall survival; MEL, melphalan; CR, complete response; NA, not applicable; G-CSF, granulocyte colony-stimulating factor; DEX, dexamethasone; VAD, vincristine, adriamycin, DEX; VMCP, vincristine, MEL, cyclosphosphamide, prednisone (alternates with VBAP every 3 weeks); BVAP, BCNU (carmustine), vincristine, doxorubicin, prednisone; ABCM, adriamycin (doxorubicin), BCNU (carmustine), cyclophosphamide, MEL; CVAMP, cyclophosphamide, vincristine, adriamycin (doxorubicin), methylprednisolone (prednisone), cisplatin; EDAP, etoposide (VP-16), dexamethasone, Ara-C (cytarabine), cisplatin; FU, follow-up | ||||||||||||||||
Attal2 | Pre-Rx | SDT | VMCP/BVAP × 18 | IFN | 100 | 58 | 108 | 14 | <.001 | 18 | NA | .01 | 44 | 20 (7 yr) | .03 | |
HDT | VMCP/BVAP × 4–6 → CTX | MEL 140 + TBI 8Gy | IFN | 100 | 57 | 38 | 28 | NA | 57 | 35 (7 yr) | ||||||
Child3 MRC VII | Pre-Rx | SDT | ABCM × 4–12 | IFN | 200 | 56 | 42 | 8 | <.001 | 20 | 16 (4 yr) | <.001 | 42 | 46 (4 yr) | .04 | |
HDT | CVAMP × 3 → CTX | MEL 200 | IFN | 201 | 55 | 44 | 32 | 36 (4 yr) | 54 | 55 (4 yr) | ||||||
Bladé4 PETHEMA | Responders to Iinduction | SDT | VBMCP/VBAD × 12 | IFN + DEX | 83 | 56 | 66 | 11 | .002 | 34 | NA | NS | 67 | NA | NS | |
HDT | VBMCP/VBAD × 4 | MEL 200 | IFN + DEX | 81 | 56 | 30 | 43 | NA | 65 | NA | ||||||
Attal5 IFM 94 | Pre-Rx | HDT ×1 | VAD × 3–4 → G-CSF | MEL 140 + TBI 8 Gy | IFN | 199 | 52 | 75 | 42 ≥ n-CR | 0.1 | 25 | 10 (7yr) | .03 | 48 | 21 (7 yr) | .01 |
HDT ×2 | VAD × 3–4 → G-CSF | MEL 140 →MEL 140 + TBI 8Gy | IFN | 200 | 52 | 50 ≥ n-CR | 30 | 20 (7 yr) | 58 | 42 (7 yr) | ||||||
Cavo8 BOLOGNA 96 | Pre-Rx | HDT ×1 | VAD × 4 → CTX | MEL 200 | 110 | 53 | 38 | 21 | NS | 25 | NA | .05 | 56 | NS | ||
HDT ×2 | VAD × 4 → CTX | MEL 200→MEL 120 + Busulfan | 110 | 53 | 24 | 34 | NA | 60 | ||||||||
Fermand6 | Pre-Rx | HDT ×1 | DEX × 2 → CTX → | MEL 140 + BCNU + | 97 | 50 | 53 | 39 | NS | 31 | NA | NS | 49 | NA | .14 | |
MAG95 | VAD × 3–4 | VP16 + CTX + TBI 12Gy | ||||||||||||||
HDT ×2 | DEX × 2 → CTX → VAD × 3–4 | MEL 140→MEL 140 + VP16 + TBI 12Gy | 96 | 50 | 37 | 33 | NA | 73 | NA | |||||||
Sonneveld1 HOVON | After VAD +/- Response | IDT | VAD × 3–4 → CTX | MEL 70 × 2 | IFN | 129 | 55 | 40 | 14 | .004 | NA | 15 (4 yr) | .03 | NA | 55 (4 yr) | .3 |
IDT/HDT | VAD × 3–4 → CTX | MEL 70 × 2 → CTX + TBI 9Gy | IFN | 132 | 56 | 28 | NA | 29 (4 yr) | NA | 50 (4 yr) | ||||||
Barlogie17 TTI vs SWOG | Historical Controls | SDT | VMCP(P) / VBAP(P) / VAD | IFN | 152 | 52 | 114 | NA | 16 | 5 (10 yr) | <.0001 | 43 | 15 (10 yr) | <.0001 | ||
HDT ×2 | VAD × 2–3 → CTX → EDAP | MEL 200 × 2 (< PR, MEL 140 + TBI 8.5 Gy) | IFN | 152 | 52 | 41 | 37 | 15 (10 yr) | 79 | 33 (10 yr) |
. | . | . | . | . | . | . | . | . | . | . | EFS . | OS . | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Author . | Randomization . | Regimen* . | SDT Regimen . | HDT Regimen . | Maintenance . | N . | Age . | Median FU / mos . | % CR . | P . | Median Mos. . | % Yr . | EFS p . | Median Mos. . | % Yr. . | OS P . |
Abbreviations: SDT, standard dose therapy; HDT, high-dose therapy; IDT, intermediate-dose therapy; IFN, interferon; TBI, total body irradiation; MEL, melphalan; OS, overall survival; MEL, melphalan; CR, complete response; NA, not applicable; G-CSF, granulocyte colony-stimulating factor; DEX, dexamethasone; VAD, vincristine, adriamycin, DEX; VMCP, vincristine, MEL, cyclosphosphamide, prednisone (alternates with VBAP every 3 weeks); BVAP, BCNU (carmustine), vincristine, doxorubicin, prednisone; ABCM, adriamycin (doxorubicin), BCNU (carmustine), cyclophosphamide, MEL; CVAMP, cyclophosphamide, vincristine, adriamycin (doxorubicin), methylprednisolone (prednisone), cisplatin; EDAP, etoposide (VP-16), dexamethasone, Ara-C (cytarabine), cisplatin; FU, follow-up | ||||||||||||||||
Attal2 | Pre-Rx | SDT | VMCP/BVAP × 18 | IFN | 100 | 58 | 108 | 14 | <.001 | 18 | NA | .01 | 44 | 20 (7 yr) | .03 | |
HDT | VMCP/BVAP × 4–6 → CTX | MEL 140 + TBI 8Gy | IFN | 100 | 57 | 38 | 28 | NA | 57 | 35 (7 yr) | ||||||
Child3 MRC VII | Pre-Rx | SDT | ABCM × 4–12 | IFN | 200 | 56 | 42 | 8 | <.001 | 20 | 16 (4 yr) | <.001 | 42 | 46 (4 yr) | .04 | |
HDT | CVAMP × 3 → CTX | MEL 200 | IFN | 201 | 55 | 44 | 32 | 36 (4 yr) | 54 | 55 (4 yr) | ||||||
Bladé4 PETHEMA | Responders to Iinduction | SDT | VBMCP/VBAD × 12 | IFN + DEX | 83 | 56 | 66 | 11 | .002 | 34 | NA | NS | 67 | NA | NS | |
HDT | VBMCP/VBAD × 4 | MEL 200 | IFN + DEX | 81 | 56 | 30 | 43 | NA | 65 | NA | ||||||
Attal5 IFM 94 | Pre-Rx | HDT ×1 | VAD × 3–4 → G-CSF | MEL 140 + TBI 8 Gy | IFN | 199 | 52 | 75 | 42 ≥ n-CR | 0.1 | 25 | 10 (7yr) | .03 | 48 | 21 (7 yr) | .01 |
HDT ×2 | VAD × 3–4 → G-CSF | MEL 140 →MEL 140 + TBI 8Gy | IFN | 200 | 52 | 50 ≥ n-CR | 30 | 20 (7 yr) | 58 | 42 (7 yr) | ||||||
Cavo8 BOLOGNA 96 | Pre-Rx | HDT ×1 | VAD × 4 → CTX | MEL 200 | 110 | 53 | 38 | 21 | NS | 25 | NA | .05 | 56 | NS | ||
HDT ×2 | VAD × 4 → CTX | MEL 200→MEL 120 + Busulfan | 110 | 53 | 24 | 34 | NA | 60 | ||||||||
Fermand6 | Pre-Rx | HDT ×1 | DEX × 2 → CTX → | MEL 140 + BCNU + | 97 | 50 | 53 | 39 | NS | 31 | NA | NS | 49 | NA | .14 | |
MAG95 | VAD × 3–4 | VP16 + CTX + TBI 12Gy | ||||||||||||||
HDT ×2 | DEX × 2 → CTX → VAD × 3–4 | MEL 140→MEL 140 + VP16 + TBI 12Gy | 96 | 50 | 37 | 33 | NA | 73 | NA | |||||||
Sonneveld1 HOVON | After VAD +/- Response | IDT | VAD × 3–4 → CTX | MEL 70 × 2 | IFN | 129 | 55 | 40 | 14 | .004 | NA | 15 (4 yr) | .03 | NA | 55 (4 yr) | .3 |
IDT/HDT | VAD × 3–4 → CTX | MEL 70 × 2 → CTX + TBI 9Gy | IFN | 132 | 56 | 28 | NA | 29 (4 yr) | NA | 50 (4 yr) | ||||||
Barlogie17 TTI vs SWOG | Historical Controls | SDT | VMCP(P) / VBAP(P) / VAD | IFN | 152 | 52 | 114 | NA | 16 | 5 (10 yr) | <.0001 | 43 | 15 (10 yr) | <.0001 | ||
HDT ×2 | VAD × 2–3 → CTX → EDAP | MEL 200 × 2 (< PR, MEL 140 + TBI 8.5 Gy) | IFN | 152 | 52 | 41 | 37 | 15 (10 yr) | 79 | 33 (10 yr) |