12th Congress of the European Hematology ... - Haematologica

12 th Congress of the European Hematology Association
0446
THALIDOMIDE-DEXAMETHASONE VERSUS MELPHALAN-PREDNISOLONE AS FIRST LINE
TREATMENT IN ELDERLY PATIENTS WITH MULTIPLE MYELOMA: SECOND INTERIM
ANALYSIS
H. Ludwig, 1 E. Tóthová, 2 R. Hajek, 3 J. Drach, 4 B. Labar, 5 M. Egyed, 6
I. Spicka, 7 H. Gisslinger, 8 R. Greil, 9 M. Fridrik, 10 N. Zojer, 1 I. Kuhn, 11
W. Linkesch, 12 M. Mistrik, 13 B. Jaksic, 14 R. Kusec, 14 A. Hinke15 1 Wilhelminenspital, VIENNA, Austria; 2 Faculty Hospital with Polyclinic Kosice,
KOαICE, Slovak Republic; 3 Faculty Hospital Brno, BRNO, Czech Republic;
4University Hospital Vienna, VIENNA, Austria; 5 Clinical Hospital „Rebro„,
ZAGRAB, Croatia; 6 Kasposi Mór County Hospital, KAPOSVÁR, Hungary;
7 Charles University, PRAGUE, Czech Republic; 8 University Hospital of Vienna,
VIENNA, Austria; 9 Landesklinik für Innere Medizin III, SALZBURG,
Austria; 10 Allgemeines Krankenhaus Linz, LINZ, Austria; 11 Schering-Plough,
TRAISKIRCHEN, Austria; 12 University Hospital Graz, GRAZ, Austria; 13 Hospital
of St. Cyril and Method, BRATISLAVA, Slovak Republic; 14 Kl. Krank.
Merkur, ZAGREB, Croatia; 15 WISP Research Institute, LANGENFELD, Germany
Background. Thalidomide-Dexamethasone (TD) is an active regimen
both in patients with relapsing/refractory and in previously untreated
patients with multiple myeloma. Aims. In the present trial we compare
TD with standard Melphalan-Prednisone (MP) in previously untreated
elderly patients with multiple myeloma. Methods. 276 patients have
been enrolled so far (median age: 72 years, stage I: 12 (4%), stage II: 91
(33%), stage III: 173 (63%). Patients are randomized to Thalidomide
200mg/day and Dexamethasone 40 mg, days 1-4 and 15-18 (on odd
cycles) and days 1-4 (on even cycles) or Melphalan 2.5mg/kg day 1-4 and
Prednisone 2 mg/kg days 1-4, q 4-6 weeks. Thalidomide should be dosed
up to 400 mg/day, if feasible. Patients achieving response or stabilization
are randomized to maintenance treatment either with Thalidomide
(maximal dose 200 mg/day)-Interferon alpha-2b (3Mega U, TIW) or
Interferon alpha-2b (3Mega U/TIW). All patients are scheduled for
monthly Zometa (4mg) during the entire period. Response is defined
according Blade's criteria, plus nCR defined as IF positive CR and VGPR
defined as >90% reduction in PP. Statistical results are given by intend
to treat and per protocol analysis. Results. 197 patients are evaluable for
response as yet. Best response to TD was: CR 7 (7%), nCR 20 (21%),
and VGPR 13 (14%) PR 16 (17%), MR 10 (10%) yielding an ORR (CR-
PR) of 58%. The respective results in patients on MP were: CR 4 (4%),
nCR 10 (10%), VGPR 11 (11%), PR 25 (25%), MR 16 (16%), ORR 50%
(ORR in TD vs. MP p=0.051). Analysis per protocol revealed an ORR of
72% in the TD and 52% in the MP group (p