MMY 2002: all centres/groups, trials/strata and treatments

Key: Green - ineligible for overview, nonstandard randomisation or otherwise excluded; Blue - data not (yet) received

14 Cancer and Leukemia Group B (CALGB), U.S.A. {Hars: FEB-2002}

1420 85D CALGB 8514: No Prior Chemotherapy; Entry OCT-1985 to MAR-1988 (278 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

21 GATLA, Argentina {Corrado, Lastiri: DEC-2001 (REVISED VERSION)}

2103 85A GATLA 3-M-85: Induction; Entry JUL-1985 to JUN-1989 (86 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

27 Medical Research Council, U.K. {Burnett, Child, Drayson, Dunn, MacLennan, McCloskey, Milligan, Richards, Selby, Wheatley: MAR-2002 (UPDATED)}

2711 86A MRC-MYEL-6c: Bisphosphonate Therapy; Patients Who Have Completed First-Line Chemotherapy And Are On First Plateau Phase; Age < 75; Entry JUN-1986 to MAY-1992 (619 patients were entered; 7 missing)

1 (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate) / (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate + Interferon) / (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate + Pred) / (Melphalan [140mg/m²]) / (Melphalan [140mg/m²] + 6-Mercaptopurine) induction then Interferon [3MU 3/wk] maintenance until relapse + Placebo indefinitely
2 (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate) / (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate + Interferon) / (Doxorubicin + Busulphan + Cyclophosphamide + Methotrexate + Pred) / (Melphalan [140mg/m²]) / (Melphalan [140mg/m²] + 6-Mercaptopurine) induction then Interferon [3MU 3/wk] maintenance until relapse + Clodronate [1600mg po] qd indefinitely

2713 89B MRC-MYEL-6e: Maintenance; Entry APR-1989 to MAR-1995 (286 patients were entered)

1 No Further Therapy
2 Interferon

2715 93A MRC-MYEL-VII: Transplant; Age < 65; Entry OCT-1993 to OCT-2000 (407 patients were entered; 4 missing)

1 (Doxorubicin [30mg/m² iv d1] + Carmustine [30mg/m² iv d1] + Cyclophosphamide [100mg/m² po d22-25] + Melphalan [6mg/m² po d22-25] {ABCM}) q6wk until plateau or progression then Interferon [3MU sc 3/wk] maintenance indefinitely
2 (Doxorubicin [9mg/m² iv continuous d1-4] + Vincristine [0·4mg iv continuous d1-4] + Methylprednisolone [1g/m² iv over 1h d1-5] + Cyclophosphamide [500mg iv bolus d1,8,15] {C-VAMP}) q3wk until response then Melphalan [140-200mg/m²] + (Autologous Bone Marrow Transplant / Autologous Stem Cell Transplant) then Interferon [3MU sc 3/wk] maintenance indefinitely

32 Southwest Oncology Group (SWOG), U.S.A. {Anderson, Coltman, Crowley, Jacobson, Kyle: JAN-2002 (REVISED VERSION)}

3212 87C SWOG 8624 (M): Maintenance; Entry OCT-1987 to NOV-1991 (299 patients were entered; 88 missing)

1 No Further Therapy
2 Interferon

3216 94A1 SWOG 9321 / INT 0141 (IFN): Maintenance; Entry 1994 to 2000 (245 patients were entered; not received)

1 No Further Therapy
2 Interferon

3217 94A2 SWOG 9321 / INT 0141 (Transplant): Transplant; Patients who do not have an eligible sibling donor or who refuse allogeneic BMT; Age < 71; Entry 1994 to 2000 (555 patients were entered; not received)

1 (Vincristine [0·5mg iv continuous d1-4] + Doxorubicin [10mg/m² iv continuous] + Dexamethasone [40mg po d1-4,9-12,17-20] {VAD}) q5wk × 4 + Mesna [4·5g/m² iv continuous over 24h] + Cyclophosphamide [1·5g/m² iv over 1h q3h to 4·5mg/m²] then G-Colony Stimulating Factor [0·25mg/m²/d adter 1d] induction then Melphalan [140mg/m² d5 before APBSCT] then Total Body Irradiation [3Gy d4,3,2,1 before APBSCT] then Autologous Peripheral Blood Stem Cell Transplant [iv d0] then G-Colony Stimulating Factor [0·25mg/m² sc from d1] + (Interferon [3MU/m² 3/wk] / Nil) maintenance
2 (Vincristine [0·5mg iv continuous d1-4] + Doxorubicin [10mg/m² iv continuous] + Dexamethasone [40mg po d1-4,9-12,17-20] {VAD}) q5wk × 4 + Mesna [4·5g/m² iv continuous over 24h] + Cyclophosphamide [1·5g/m² iv over 1h q3h to 4·5mg/m²] then G-Colony Stimulating Factor [0·25mg/m²/d adter 1d] induction then (Vincristine [1·2mg/m² iv d1] + Carmustine [20mg/m² iv d1] + Melphalan [8mg/m² po d1-4] + Cyclophosphamide [400mg/m² iv d1] + Pred [40mg/m² po d1-7] {VBMCP}) q5wk × 12m minimum + (Interferon [3MU/m² 3/wk] / Nil) maintenance

35 PETHEMA, Spain {Bladé, Fontanillas, San Miguel: JAN-2002 (REVISED VERSION)}

3503 91C PETHEMA 1990 (M): Maintenance; Entry JAN-1991 to DEC-1994 (113 patients were entered; 21 exclusions missing)

1 No Further Therapy
2 Interferon

3504 95C PETHEMA PBSCT: Transplant; Entry APR-1995 to JUL-2000 (164 patients were entered)

1 ((Carmustine + Vincristine + Melphalan + Cyclophosphamide + Pred {BVMCP}) / (Carmustine + Vincristine + Doxorubicin + Dexamethasone {VBAD})) alternating × 4 induction then ((Melphalan [140mg/m²] + Total Body Irradiation) / Melphalan [200mg/m²])) + Autologous Peripheral Blood Stem Cell Transplant then (Interferon + Dexamethasone) maintenance
2 ((Carmustine + Vincristine + Melphalan + Cyclophosphamide + Pred {BVMCP}) / (Carmustine + Vincristine + Doxorubicin + Dexamethasone {VBAD})) alternating × 12 then (Interferon + Dexamethasone) maintenance

37 Eastern Coöperative Oncology Group (ECOG), U.S.A. {Gertz, Greipp, Kyle, Leong, Oken: DEC-2001 (REVISED VERSION)}

3707 88A1 ECOG 9486 (IFN): Induction; Entry FEB-1988 to MAY-1992 (511 patients were entered)

1 (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) × 3
2 (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) × 2 then (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) + Interferon
3 (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) × 2 then (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred + Cyclophosphamide [high dose, intensification])

3709 90C ECOG 8489: Refractory and Relapse; Entry APR-1990 to MAY-1992 (53 patients were entered)

1 (Vincristine + Doxorubicin + Dexamethasone)
2 (Vincristine + Doxorubicin + Dexamethasone) + Interferon

3710 88A2 ECOG 9486 (> 70 years): Induction; Entry MAR-1988 to MAY-1992 (142 patients were entered)

1 (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) × 3
2 (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) × 2 then (Vincristine + Carmustine + Cyclophosphamide + Melphalan + Pred) + Interferon

47 HOVON, Dutch Hemato Oncology Working Party, The Netherlands {Wijermans, Sonneveld: FEB-2002 (UPDATED)}

4701 92C HOVON 16: Maintenance; Entry OCT-1992 to SEP-1998 (90 patients were entered)

1 Observation
2 Interferon

4702 95A HOVON 24: Transplant; Patients for whom an allogeneic donor is unavailable; Stage IB/II/III; Age < 65; Entry NOV-1995 to JAN-2000 (261 patients were entered)

1 (Vincristine + Doxorubicin + Dexamethasone {VAD}) × 3-4 induction then Melphalan [70mg/m²] × 2 + Interferon maintenance
2 (Vincristine + Doxorubicin + Dexamethasone {VAD}) × 3-4 induction then Melphalan [70mg/m²] × 2 + Cyclophosphamide [120mg/kg] + Total Body Irradiation + Autologous Peripheral Blood Stem Cell Transplant + Interferon maintenance

69 Southern England Collaborative Trialists' Group, U.K. {Kranjniewski, Singer: MAR-2002}

6901 94C SECTG 9401: Transplant; Stage II/III; Patients with 50% or greater reduction in paraprotein following induction; Age < 70; Entry JAN-1994 to JUN-2001 (118 patients were entered)

1 ((Vincristine + Doxorubicin + Dexamethasone) / (Vincristine + Doxorubicin + Methotrexate + Pred)) × 4-6 induction then Melphalan [80mg/m²] + G-Colony Stimulating Factor then Interferon [3MU/m² 3/wk] maintenance
2 ((Vincristine + Doxorubicin + Dexamethasone) / (Vincristine + Doxorubicin + Methotrexate + Pred)) × 4-6 induction then Melphalan [200mg/m²] + Autologous Peripheral Blood Stem Cell Transplant then Interferon [3MU/m² 3/wk] maintenance

70 University College Hospital, London, U.K. {: 1994}

7001 87B UCH-(1987): Relapsed or Primary Chemo-Resistant; Entry 1987 to 1990 (59 patients were entered; not received)

1 Double Hemi-Body Irradiation {DHBI}
2 Double Hemi-Body Irradiation {DBHI} + Interferon

75 Bowman Gray School of Medicine, Winston-Salem, U.S.A. {: 1994}

7501 BGSM 26285: Relapsed or Refractory; Entry 198? to 1986 (? patients were entered; not received)

1 Interferon
2 Doxorubicin
3 Interferon + Doxoxrubicin

84 Memorial Sloan Kettering Cancer Center, U.S.A. {: 1994}

8403 95D MSKCC Gallium: Multiple Myeloma With Bone Involvement; Entry 1995 ff. (? patients were entered; not received; not eligible for current overview)

1 Gallium Nitrate
2 Placebo

103 Australian Leukaemia Study Group, Australia {Gibson, Joshua, Matthews, Seymour: JUN-2002 (REVISED VERSION, UPDATED)}

10301 90D ALSG Myeloma II: Induction; Entry FEB-1990 to JUL-1992 (113 patients were entered)

1 Pred + Cyclophosphamide + Doxorubicin + Carmustine
2 Pred + Cyclophosphamide + Doxorubicin + Carmustine + Interferon

116 Munich University, Germany {: 1994}

11601 Munich: Bisphosphonate Therapy; Active Myeloma Stage II or III; Entry ? (139 patients were entered; not received)

1 (Melphalan + Pred) / First-Line Chemotherapy induction then Clodronate [1600mg po] qd × 24m
2 (Melphalan + Pred) / First-Line Chemotherapy induction then Placebo × 24m

219 Finnish Leukaemia Group, Finland {Laakso, Oivanen, Palva: 1994}

21905 86B Finnish Clodronate: Bisphosphonate Therapy; Newly-Diagnosed; Previously Untreated; Entry 1986 to 1989 (350 patients were entered)

1 (Melphalan [9-12mg/m² po d1-4] + Pred [1mg/kg po d1-4]) q4wk induction then Placebo × 24m
2 (Melphalan [9-12mg/m² po d1-4] + Pred [1mg/kg po d1-4]) q4wk induction then Clodronate [2400mg po] qd × 24m

21985 86B Finnish Clodronate: Bisphosphonate Therapy; Newly-Diagnosed; Previously Untreated; Entry 1986 to 1989 (350 patients were entered - FUDGED VERSION WITH ALL LIVING PATIENTS ASSUMED FOLLOWED UP FOR 5 YEARS EXACTLY)

1 (Melphalan [9-12mg/m² po d1-4] + Pred [1mg/kg po d1-4]) q4wk induction then Placebo × 24m
2 (Melphalan [9-12mg/m² po d1-4] + Pred [1mg/kg po d1-4]) q4wk induction then Clodronate [2400mg po] qd × 24m

225 Chacabuco, Buenos Aires, Argentina {: 1984}

22501 88E Buenos Aires: Previously Untreated; Entry 1988 to 1992 (47 patients were entered; not received)

1 Vincristine + Carmustine + Doxorubicin + Pred
2 Vincristine + Carmustine + Doxorubicin + Pred + Interferon

226 National Cancer Institute of Canada {Belch, Bergsagel, Browman, Pater, Shepherd, Shustik, Tu, Zee: JAN-2002 (UPDATED)}

22604 83A1 NCI-C MY4 (low and high dose): Bisphosphonate Therapy; Newly-Diagnosed; No Previous Chemotherapy; Entry DEC-1983 to MAY-1984 (24 patients were entered; 1 missing)

1 (Methotrexate [9mg/m² d1-4] + Pred [100mg d1-4]) q4wk induction then Placebo for life
2 (Methotrexate [9mg/m² d1-4] + Pred [100mg d1-4]) q4wk induction then (Etidronate [5mg/kg po] qd ) / (Etidronate [20mg/kg po d1-28] q56d) for life

22605 83A2 NCI-C MY4 (low dose): Bone disease treatment; Entry JUN-1984 to FEB-1987 (160 patients were entered)

1 (Methotrexate [9mg/m² d1-4] + Pred [100mg d1-4]) q4wk induction then Placebo for life
2 (Methotrexate [9mg/m² d1-4] + Pred [100mg d1-4]) q4wk induction then Etidronate [5mg/kg po] qd for life

22606 87D NCI-C MY6: Maintenance; Entry AUG-1987 to SEP-1993 (181 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

228 European Myeloma Study Group {Fritz, Ludwig: 2002 (UPDATED)}

22802 87A1 EMSG 2 (I): Induction; Entry JUN-1987 to JUL-1993 (256 patients were entered)

1 Vincristine + Melphalan + Cyclophosphamide + Pred
2 Vincristine + Melphalan + Cyclophosphamide + Pred + Interferon

22803 87A2 EMSG 2 (M): Maintenance; Entry JUN-1988 to AUG-1993 (100 patients were entered)

1 No Further Therapy
2 Interferon

22804 85B EMSG 1985: Induction; Entry JAN-1985 to APR-1986 (33 patients were entered)

1 Vincristine + Melphalan + Cyclophosphamide + Pred
2 Vincristine + Melphalan + Cyclophosphamide + Pred + Interferon

230 German Myeloma Treatment Group, Germany {Buhrmester, Peest: JUN-2002 (UPDATED TWICE)}

23004 88B GMTG MM02 (M): Maintenance; Entry NOV-1988 to MAR-1992 (117 patients were entered)

1 No Further Therapy
2 Interferon

23005 92E GMTG Clodronate: Bisphosphonate Therapy; Stage IIA or IIIA; X-Ray Proven Lytic Bone Lesisons; Entry DEC-1992 to JUN-1994 (33 patients were entered)

1 (Melphalan [15mg/m² iv d1] + Pred [60mg/m² po d1-4]) q28d × 2 induction then Control
2 (Melphalan [15mg/m² iv d1] + Pred [60mg/m² po d1-4]) q28d × 2 induction then Clodronate [600mg/d over 2-4h for 1-3d] q28d × 2m

232 Italian Multiple Myeloma Study Group, Italy {Avvisati, Boccadoro, Bugliosi, Mandelli, Petrucci, Pileri, Tribalto: 2001 (UPDATED)}

23203 85C Italian M-84: Maintenance; Entry APR-1985 to MAY-1988 (101 patients were entered)

1 No Further Therapy
2 Interferon

23205 97C M97G: Transplant; Entry 1997 to 2000 (? patients were entered; not received)

1 Melphalan + Pred
2 Melphalan [100mg/m²] + Peripheral Blood Stem Cell Transplant

236 Rome, San Camillo Hospital, Italy {De Rosa, Montuoro: 1994}

23601 86C Rome IFN 1: Induction; Entry DEC-1986 to MAR-1988 (50 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

23602 89C Rome IFN 2: Induction; Entry 1989 ff. (95 patients were entered; not received)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

237 Nagoya Myeloma Coöperative Study Group, Japan {Shimizu: JAN-2002 (UPDATED)}

23701 83B Nagoya 1983: Entry SPE-1983 to APR-1987 (88 patients were entered, 5 missing; not eligible for current overview)

1 Cyclophosphamide + Pred
2 Vincristine + Melphalan + Cyclophosphamide + Pred {VMCP}

23702 87G1 Nagoya 1987: Previously Untreated; Age < 80; Entry DEC-1987 to JAN-1991 (113 patients were entered, 2 missing; not eligible for current overview)

1 Vincristine + Melphalan + Cyclophosphamide + Prednisolone {VMCP}
2 Melphalan + Methyl-Lomustine + Procarbazine + Prednisolone {MMPP}

23703 91D Nagoya 1991: Entry MAY-1991 to AUG-1995 (48 patients were entered)

1 Interferon
2 No Further Therapy

23704 87G2 Nagoya 1987 (M): Patients Achieving Partial or Minor Response During Induction and/or Crossover Therapy (23702); Entry 1987 to 1991 (25 patients were entered; not received; not eligible for current overview)

1 Melphalan + Pred
2 (Vincristine + Melphalan + Cyclophosphamide + Pred) / (Melphalan + Methyl-Lomustine + Procarbazine + Pred) alternating

238 C.M.N. Mexico {Gonzalez, De Jesus Nambo, Diaz Maqueo: 1994}

23801 89F CMN Mexico (M): Maintenance; Entry FEB-1989 to NOV-1991 (24 patients were entered; 3 missing)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon
3 Cyclophosphamide + Vincristine + Melphalan + Pred
4 Cyclophosphamide + Vincristine + Melphalan + Pred + Interferon

23802 89G CMN Mexico (I): Induction; Entry SEP-1989 to FEB-1997 (103 patients were entered; 31 missing)

1 (Cyclophosphamide + Vincristine + Melphalan + Pred) / (Cyclophosphamide + Vincristine + Mitozantrone + Pred) / (Carmustine + 4-Epi-Doxorubicin + Vincristine + Dexamethasone) alternating
2 (Cyclophosphamide + Vincristine + Melphalan + Pred) / (Cyclophosphamide + Vincristine + Mitozantrone + Pred) / (Carmustine + 4-Epi-Doxorubicin + Vincristine + Dexamethasone) alternating + Interferon

239 Nordic Myeloma Study Group {Hippe, Hjorth, Holmberg, Kjaergaard, Rödjer, Turesson, Westin, Wisløff: 2002 (UPDATED)}

23902 90E NMSG 04-90: Induction; Entry JUN-1990 to NOV-1992 (593 patients were entered; 10 missing)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

242 Myeloma Group of Central Sweden {Björkholm, Mellstedt, Österborg, Zador: 1994}

24205 86D MGCS 1986: Induction; Entry APR-1986 to SEP-1991 (335 patients were entered; 1 missing)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

24206 80A MGCS MM-IFN-78b: Induction; Entry MAY-1980 to SEP-1980 (25 patients were entered)

1 Melphalan + Pred
2 Interferon [3MU/d]
3 Interferon [6MU/d]

243 Myeloma Group of Western Sweden (extended) {Rödjer, Turesson, Westin: 2002 (UPDATED)}

24301 87E MGWS extended: Maintenance; Entry OCT-1987 to MAY-1990 (125 patients were entered)

1 No Further Therapy
2 Interferon

246 CRC Section of Medicine, Royal Marsden, U.K. {Malpas, Powles, Siroho: FEB-2002 (REVISED VERSION)}

24602 88C Marsden (M): Maintenance; Entry JUN-1988 to APR-1992 (84 patients were entered)

1 No Further Therapy
2 Interferon

248 Milton S. Hershey Medical Center, U.S.A. {: 1994}

24802 Hershey Bisphosphonate: (Breast Cancer) and Multiple Myeloma With Osteolytic Lesions; Entry ? (109 patients were entered; not received; not eligible for current overview)

1 Zoledronate [0·4mg]
2 Zoledronate [2mg]
3 Zoledronate [4mg]
4 Pamidronate [90mg]

275 Prague, Czech Republic {Slaby: 1994}

27501 93C Prague: Bone disease treatment; Entry 1993 to 1994 (22 patients were entered; not received)

1 Clodronate [800mg po tds] × 12m or more
2 Control

304 Lyon, Hopital Edouard Herriot, France {Delmas, Fontana: 1994}

30401 82A Lyon Clodronate: Bisphosphonate Therapy; < 11 Previous Courses of Chemotherapy; Entry 1982 to 1982 (13 patients were entered; not received)

1 (Methotrexate + Pred) [1wk course] q6wk / (Vincristine + Methotrexate + Cyclophosphamide + Pred) q3wk + Placebo × 18m
2 (Methotrexate + Pred) [1wk course] q6wk / (Vincristine + Methotrexate + Cyclophosphamide + Pred) q3wk + Clodronate [800mg po bd] × 18m

307 Spanish Coöperative Group, Spain {Garcia-Larana: JAN-2002}

30701 89D Spanish IFN: Induction; Entry JAN-1989 to JAN-1994 (88 patients were entered; 4 missing)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

308 Grupo Multicentrico Mexicano, Mexico {Vela-Ojeda: 1994}

30801 91A Grupo Mexicano (I): Induction; Entry JAN-1991 to FEB-1997 (148 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon
3 Cyclophosphamide + Vincristine + Melphalan + Pred
4 Cyclophosphamide + Vincristine + Melphalan + Pred + Interferon

30802 90A Grupo Mexicano (M): Maintenance; Entry 1990 to 1997 (150 patients were entered; not received)

1 No Further Therapy
2 Interferon

345 Royal London Hospital, U.K. {Aitchison, Cavenagh: 1994}

34501 87F Royal London: Induction; Entry AUG-1987 to NOV-1990 (34 patients were entered)

1 Cyclophosphamide
2 Cyclophosphamide + Interferon

346 Avicenne Hospital / Intergroupe Français du Myelome (IFM), France {Casassus, Harousseau: 1994}

34601 89A1 KIF: Induction; Entry JUL-1989 to MAY-1995 (300 patients were entered; 17 missing)

1 (Vincristine + Melphalan + Cyclophosphamide + Pred {VMCP}) / (Vincristine + Carmustine + Doxorubicin + Pred {VBAP})
2 (Vincristine + Melphalan + Cyclophosphamide + Pred {VMCP}) / (Vincristine + Carmustine + Doxorubicin + Pred {VBAP}) + Interferon

34602 89A2 KIF (dose): Unknown; Entry 1989 ff. (145 patients were entered; not received)

1 Interferon [3MU/m² × 3/wk]
2 Interferon [1MU × 3/wk]

347 Italian Non-Hodgkin's Lymphoma Coöperative Study Group (NHLCSG), Italy {: 1994}

34701 90H1 Italian NHLSG (LR): Low Risk (Good Prognosis); Entry 1990 ff. (67 patients were entered)

1 Melphalan + Pred
2 Melphalan + Pred + Interferon

34702 90H2 Italian NHLSG (Maint): Entry 1990 ff. (92 patients were entered)

1 No Further Therapy
2 Interferon

34703 90H3 Italian NHLSG (HR): High Risk (Good Prognosis); Entry 1990 ff. (41 patients were entered)

1 Vincristine + Melphalan + Cyclophosphamide + Pred {VMCP}
2 Vincristine + Peptichm + Pred {VPP}

351 Groupe d'Etudes et de Recherche sur le Myelome (GERM), France {Daragon, Grosbois, Mary: MAR-2002}

35101 90B GERM 1990 (IFN): Maintenance; Entry JUL-1990 to JAN-1995 (136 patients were entered)

1 Observation
2 Interferon

35104 85E GERM 1985 (Etidronate): Bisphosphonate Therapy; Previously-Untreated Multiple Myeloma; Durie-Salmon Stage II and III; Age < 80; Entry 1985 to 1990 (94 patients were entered; not received)

1 (Cyclophosphamide [800mg/m² iv d1] + Pred [60mg/m² po d1-4]) q21d induction then Etidronate [10mg/kg po] qd × 4m
2 (Cyclophosphamide [800mg/m² iv d1] + Pred [60mg/m² po d1-4]) q21d induction then Placebo × 4m

352 Warsaw, Poland {Kraj: 1994}

35202 95B Warsaw Pamidronate: Bisphosphonate Therapy; Stage III; Osteolytic Lesions; Entry 1995 ff. (46 patients were entered; not received)

1 (Vincristine + Methotrexate + Cyclophosphamide + Pred) / (Vincristine + Busulphan + Doxorubicin + Pred) alternating q4wk induction then Pamidronate [60mg iv over 4h] q1m × 12m or more
2 (Vincristine + Methotrexate + Cyclophosphamide + Pred) / (Vincristine + Busulphan + Doxorubicin + Pred) alternating q4wk induction then Control

35299 93D Warsaw Clodronate: Bone disease treatment; Entry 1993 to 1996 (60 patients were entered; not randomised; not received)

1 Clodronate
2 Control

356 Myelome-Autogreffe Group, France {Fermand: MAR-2002}

35601 89H MAG 90: Transplant; Stable Stage I Excluded; Age < 56; Entry DEC-1989 to JUL-1995 (185 patients were entered)

1 (Vincristine [0·4mg iv continuous d1-4] + Doxorubicin [9mg/m² iv continuous d1-4] + 6-Mercaptopurine [0·4g iv continuous d1-4]) qm × 3-4 [early high-dose therapy] + (Lomustine [120mg/m² 8d before APBSCT] + Etoposide [250mg/m² 8-6d before APBSCT] + Cyclophosphamide [60mg/kg 5d before APBSCT] + Melphalan [140mg/m² 4d before APBSCT]) + Total Body Irradiation [12Gy in 6 fractions 1-3d before APBSCT] then Autologous Peripheral Blood Stem Cell Transplant + Interferon [3MU sc 3/wk] maintenance until persisting side effects
2 Vincristine [1·4mg/m² iv d1] + Melphalan [6mg/m² po d1-4] + Cyclophosphamide [600mg/m² iv d1] + Pred [80mg/m² po d1-4] {VMCP}) qm until progression, resistance or plateau [crossover to Arm 1 for rescue therapy] + Interferon [3MU sc 3/wk] maintenance until persisting side effects

35602 96B MAG 95: Transplant; Newly-Diagnosed Symptomatic; Age < 56; Entry 1996 ff. (230 patients were entered; not received)

1 Carmustine + Etoposide + Melphalan [140mg/m²] + Cyclophosphamide [60mg/kg] + Total Body Irradiation [12Gy in 6 fractions] + Peripheral Blood Stem Cell Transplant (unselected) [single transplant, no CD34 selection]
2 Carmustine + Etoposide + Melphalan [140mg/m²] + Cyclophosphamide [60mg/kg] + Total Body Irradiation [12Gy in 6 fractions] + Peripheral Blood Stem Cell Transplant (CD34-enriched) [single transplant, CD34 selection]
3 (Melphalan [140mg/m²] + Peripheral Blood Stem Cell Transplant (unselected)) then (Carmustine + Etoposide + Melphalan [140mg/m²] + Cyclophosphamide [60mg/kg] + Total Body Irradiation [12Gy in 6 fractions] + Peripheral Blood Stem Cell Transplant (unselected)) [double transplant, no CD34 selection]
4 (Melphalan [140mg/m²] + Peripheral Blood Stem Cell Transplant (unselected)) then (Carmustine + Etoposide + Melphalan [140mg/m²] + Cyclophosphamide [60mg/kg] + Total Body Irradiation [12Gy in 6 fractions] + Peripheral Blood Stem Cell Transplant (CD34-enriched)) [double transplant, CD34 selection]

35603 92A MAG 91: Transplant; Age 55-65; Entry 1992 ff. (191 patients were entered; not received)

1 (Vincristine [0·4mg d1-4] + Doxorubicin [9mg/m² d1-4] + Dexamethasone [40mg d1-4] {VAD}) qm × 3 + (Melphalan [200mg/m²] / (Melphalan [140mg/m²] + Busulphan [16mg/kg po])) then Autologous Peripheral Blood Stem Cell Transplant
2 (Vincristine [1mg/m² d1] + Melphalan [5mg/m² d1-4] + Cyclophosphamide [100mg/m² d1-4] + Pred [60mg/m² d1-4] {VMCP}) qm until plateau

360 Myeloma Aredia Study Group {: 1994}

36001 90J Aredia SG: Bisphosphonate Therapy; Stage III Multiple Myeloma With At Least One Osteolytic Lesion; Entry 1990 to 1993 (392 patients were entered; not received)

1 (Melphalan [0·25mg/kg po d1-4] + Pred [100mg po d1-4] + Interferon [5MU sc 3/wk]) / (Melphalan [0·25mg/kg po d1-4] + Pred [100mg po d1-4]) induction then Pamidronate [150mg po bd] × 24m or more + Interferon [5MU sc 3/wk] continued during maintenance and relapse
2 Placebo × 24m or more + Interferon [5MU sc 3/wk] continued during maintenance and relapse

368 Heidelberg University, Germany {Goldschmidt: 2001}

36801 92D Heidelberg 1992: Entry 1992 to 1996 (100 patients were entered; not received; not eligible for current overview)

1 Total Body Irradiation + Melphalan [140mg/m²]
2 Melphalan [200mg/m²]

36802 Heidelberg: Transplant; Previously-Untreated Patients With Multiple Myeloma; Entry ? (? patients were entered; not received)

1 (Vincristine [0·4mg iv d1-4] + Doxorubicin [9mg/m² iv d1-4] + Dexamethasone [40mg d1-4,9-12,17-20]) / (Vincristine [2mg iv d1] + Idarubicin [10mg/m² po d1-4] + Dexamethasone [40mg d1-4,9-12,17-20]) × 3-6 induction then (Melphalan [high dose] + Autologous Stem Cell Transplant) [single transplant]
2 (Vincristine [0·4mg iv d1-4] + Doxorubicin [9mg/m² iv d1-4] + Dexamethasone [40mg d1-4,9-12,17-20]) / (Vincristine [2mg iv d1] + Idarubicin [10mg/m² po d1-4] + Dexamethasone [40mg d1-4,9-12,17-20]) × 3-6 induction then (Melphalan [high dose] + Autologous Stem Cell Transplant) × 2 [double transplant]

371 Intergroupe Français du Myelome (IFM), France {Attal, Facon, Harousseau, Mary: OCT-2001}

37101 90G IFM 90/GEM-POF: Transplant; Stage II or III; Age < 65; Entry MAY-1990 to MAY-1993 (204 patients were entered; 4 missing)

1 ((Vincristine [1mg iv d1] + Melphalan [5mg/m² po d1-4] + Cyclophosphamide [110mg/m² po d1-4] + Pred [60mg/m² po d1-4]) / (Carmustine [30mg/m² iv d1] + Vincristine [1mg iv d1] + Doxorubicin [30mg/m² iv d1] + Pred [60mg/m² po d1-4] {BVAP})) q3wk alternating × 18 + Interferon [3MU/m² 3/wk] maintenance from cycle 9 or haematological reconstitution until relapse
2 ((Vincristine [1mg iv d1] + Melphalan [5mg/m² po d1-4] + Cyclophosphamide [110mg/m² po d1-4] + Pred [60mg/m² po d1-4]) / (Carmustine [30mg/m² iv d1] + Vincristine [1mg iv d1] + Doxorubicin [30mg/m² iv d1] + Pred [60mg/m² po d1-4] {BVAP})) q3wk alternating × 4-6 then (Autologous Bone Marrow Transplant + Melphalan + Total Body Irradiation [8Gy in 4 fractions over 4d]) + Interferon [3MU/m² 3/wk] maintenance from cycle 9 or haematological reconstitution until relapse

37102 94D IFM 94: Transplant; Any Stage; Age < 60; Entry 1994 to 1997 (405 patients were entered; not received)

1 (Vincristine + Doxorubicin + Dexamethasone) × 3 induction then (Melphalan [140mg/m²] + Total Body Irradiation [8Gy] + (Autologous Stem Cell Transplant / Autologous Bone Marrow Transplant)) [single transplant]
2 (Vincristine + Doxorubicin + Dexamethasone) × 3 induction then (Melphalan [140mg/m²] + Autologous Peripheral Blood Stem Cell Transplant) then (Melphalan [140mg/m²] + Total Body Irradiation [8Gy] + (Autologous Stem Cell Transplant / Autologous Bone Marrow Transplant)) [double transplant]

37104 92B IFM CIAM: Transplant; Stage II/III; Age < 60; Entry 1992 ff. (165 patients were entered; not received)

1 (Vincristine + Doxorubicin + Dexamethasone) (usually) × 0-6 + G-Colony Stimulating Factor induction then Total Body Irradiation [12Gy] + Melphalan [140mg/m²] + Interferon [3MU/m² 3/wk] maintenance + Autologous Bone Marrow Transplant (as rescue therapy)
2 (Vincristine + Doxorubicin + Dexamethasone) (usually) × 0-6 + G-Colony Stimulating Factor induction then Total Body Irradiation [12Gy] + Melphalan [140mg/m²] + Autologous Bone Marrow Transplant (front line) + Interferon [3MU/m² 3/wk] maintenance

382 Ancona, Italy {Offidani: JAN-2002}

38201 89E Ancona: Maintenance; Entry AUG-1989 to MAR-1994 (52 patients were entered)

1 Interferon [3MU × 3/wk]
2 Interferon [3MU/d]

383 Danish-Swedish Co-Operative Study Group {: 1994}

38301 90K Danish-Swedish: Newly-Diagnosed Multiple Myeloma; Entry 1990 to 1993 (304 patients were entered; not received)

1 Pamidronate
2 Placebo

384 Bad Sooden-Allendorf, Germany {Edler, Heim: MAR-2002 (UPDATED)}

38401 88D Bad Sooden-Allendorf: Bisphosphonate Therapy; Multiple Myeloma Requiring Treatment And With Bone Involvement; Entry SEP-1988 to NOV-1992 (170 patients were entered)

1 (Melphalan [15mg/m² iv d1] + Pred [60mg/m² po d1-4]) q4wk induction then Clodronate [1600mg po] qd × 12m
2 (Melphalan [15mg/m² iv d1] + Pred [60mg/m² po d1-4]) q4wk induction then Control

385 Japanese Co-Operative Study Group for the Treatment of Multiple Myeloma {Ohno, Wada: NOV-2001 (REVISED VERSION)}

38501 92F Japanese Co-Op: Maintenance; Entry JAN-1992 to JAN-1995 (83 patients were entered)

1 Interferon
2 No Further Therapy

387 University of Athens Medical School, Laiko Hospital / General Air Force Hospital, Athens, Greece {Terpos: JAN-2002}

38701 97A Athens: Bisphosphonate Therapy; Entry JAN-1997 to JAN-1999 (62 patients were entered)

1 (Melphalan + Pred) / (Vincristine + Doxorubicin + Dexamethasone) induction then Pamidronate [90mg iv] q1m × 14m or more
2 (Melphalan + Pred) / (Vincristine + Doxorubicin + Dexamethasone) induction then Control

388 Zaragoza, Spain {Giraldo: 1994}

38801 Zaragoza: Bisphosphonate Therapy; Symptomatic Disease; Entry ? (27 patients were entered; not received)

1 (Melphalan + Pred) + ((Vincristine + Methotrexate + Cyclophosphamide + Pred) / (Vincristine + Busulphan + Doxorubicin + Pred) alternating) induction then Clodronate [300mg iv over 2h] × 5d then Clodronate [1600mg po] qd × 12m
2 (Melphalan + Pred) + ((Vincristine + Methotrexate + Cyclophosphamide + Pred) / (Vincristine + Busulphan + Doxorubicin + Pred) alternating) induction then Placebo

389 West German Myeloma Study Group {Schneider: 1994}

38901 97B West German: Transplant; Entry 1997 to 1999 (56 patients were entered; not received; not eligible for current overview)

1 Melphalan
2 Idarubicin + Melphalan + Cyclophosphamide

390 University of Bologna, Italy {Cavo: 1994}

39001 96A Bologna 96: Transplant; Symptomatic, Progressive Stage I and Stages II-III; Age < 61; Entry 1996 to 2002 (320 patients were entered by 2000; not received)

1 (Vincristine + Doxorubicin + Dexamethasone) × 4 induction then (Melphalan [200mg/m²] + Autologous Peripheral Blood Stem Cell Transplant) [single transplant] then Interferon [3MU/m² 3/wk] maintenance
2 (Vincristine + Doxorubicin + Dexamethasone) × 4 induction then (Melphalan [200mg/m²] + Autologous Peripheral Blood Stem Cell Transplant) then (Melphalan [120mg/m²] + Busulphan [12mg/kg] + Autologous Peripheral Blood Stem Cell Transplant) [double transplant] then Interferon [3MU/m² 3/wk] maintenance

391 Italian Coöperative Study Group for Immunoproliferative Diseases {: 1994}

39101 Italian Coöperative: Resistant or Relapsed; Entry ? (104 patients were entered; not received)

1 Cyclophosphamide + Dexamethasone
2 Cyclophosphamide + Dexamethasone + Interferon

392 Myeloma Ibandronate Study Group {: 2002}

39201 94B Myeloma Ibandronate SG: Bisphosphonate Therapy; Stage II or III; at least one osteolytic lesion; Entry JAN-1994 to JUN-1996 (214 patients were entered; not received)

1 Ibandronate [2mg iv bolus] q1m × 24m
2 Placebo × 24m

[End of document, updated to 25 June 2002]

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