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Title: A randomized phase 3 study on the effect of thalidomide combined with adriamycin, dexamethasone, and high-dose melphalan, followed by thalidomide maintenance in patients with multiple myeloma
Authors: Lokhorst, H M ×
van der Holt, B
Zweegman, S
Vellenga, E
Croockewit, S
van Oers, M H
von dem Borne, P
Wijermans, P
Schaafsma, R
de Weerdt, O
Wittebol, S
Delforge, Michel
Berenschot, H
Bos, G M
Jie, K S
Sinnege, H
van Marwijk-Kooy, M
Joosten, P
Minnema, M C
Ammerlaan, R
Sonneveld, P #
Issue Date: Feb-2010
Publisher: W.B. Saunders
Series Title: Blood vol:115 issue:6 pages:1113-1120
Abstract: The phase III trial HOVON-50 was designed to evaluate the effect of thalidomide during induction treatment and as maintenance in patients with Multiple Myeloma (MM) who were transplant candidates. 556 patients were randomly assigned to arm A: 3 cycles of Vincristine, Doxorubicin, Dexamethasone (VAD) or to arm B, Thalidomide 200 orally, days 1-28 + AD (TAD). After induction therapy and stem cell mobilization patients were to receive High Dose Melphalan 200mg/m(2) (HDM) followed by maintenance with alpha- Interferon (Arm A) or Thalidomide 50 mg daily (Arm B). Thalidomide significantly improved overall response rate (ORR) as well as quality of the response before and after HDM. Best ORR on protocol was 88% and 79 % (p=0.005), at least Very Good Partial Remission (VGPR) 66 % and 54% (p=0.005), Complete remission (CR) 31% and 23 % (p=0.04), respectively in favour of the Thalidomide arm. Thalidomide also significantly improved Event Free Survival (EFS) from median 22 months to 34 months (p<0.001) and PFS from median 25 to 34 months (p<0.001). Median survival was longer in the thalidomide arm, 73 versus 60 months, however this difference was not significant (P=0.77). Patients randomized to thalidomide had strongly reduced survival after relapse. This trial was registered on www.controlled-trials.com as ISRCTN06413384.
ISSN: 0006-4971
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hematology Section (-)
× corresponding author
# (joint) last author

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