[Autologous transplantation of peripheral hematopoietic cells and subsequent maintenance therapy with interferon alpha or interferon alpha and dexamethasone in patients with multiple myeloma--results from the 4W randomized clinical trial of the Czech Myeloma Group].
In the clinical 4W study patients with newly diagnosed multiple myeloma are included where the state of the disease calls for treatment, while high dose chemotherapy is not contraindicated. Treatment according to protocol 4W comprises induction chemotherapy VAD, mobilization of haematopoietic cells (cyclophosphamide 5 g/m2). This is followed by autologous transplantation (as a conditioning regime melfalan 200 mg/m2 is administered). The patients are randomized into two groups, the first one is given interferon alpha as maintenance treatment, in the second group alternates cyclically interferon alpha and dexamethasone treatment. So far between 1996 and Aug. 31 2000 in the 4W clinical study 167 patients were included. 113 patients after transplantation were evaluated incl. 13 (12%) who achieved complete remission of the disease (absence of paraprotein, negative immunofixation), 63 patients (56%) with remission of the disease (decline of paraprotein, by more than 75%). Another 24 patients (21%) achieved partial remission (decline of paraprotein by more than 50% but less than 75%). The peritransplantation mortality is 2.67%. So far there is no significant difference between the two groups on maintenance treatment as regards the mean period before a relapse of the disease (p = 0.567). The median of the mean survival was not reached so far. The authors describe the results of the internal analysis of data incl. statistical processing.
Krejcí
M
M
Interní hematoonkologická klinika Fakultní nemocnice Brno.
Hájek
R
R
Scudla
V
V
Bacovský
J
J
Indrák
K
K
Faber
E
E
Koza
V
V
Schützová
M
M
Kuca
B
B
Sumná
E
E
Franková
H
H
Lehanka
F
F
Gumulec
J
J
Stavarová
Y
Y
Rezek
Z
Z
Praskac
P
P
Cahová
S
S
Vránová
M
M
Veprek
K
K
Januska
J
J
Kessler
P
P
Pozdĕnová
V
V
Walterová
L
L
Stefánek
I
I
Hausdorf
P
P
Meluzínová
I
I
Novosadová
L
L
Lenícková
S
S
Dusek
L
L
Syobodník
A
A
Králová
E
E
Adam
Z
Z
Mayer
J
J
Vorlícek
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D012074:Remission Induction; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous
D016898:Interferon-alpha; D003907:Dexamethasone