HOVON HO49

Archived

Main info

Identifier:
HOVON 49 MM
Sponsor:
HOVON
Active sites:
0
(of 1)
52 sites are pending
Title:

Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.

Timeline

Scheduled
Actual
2002
01 Aug
Activated
2007
15 Jul
CloseoutInProgressLastPtOutActualStart
2017
15 Jul
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria (Appendix A)
  • Age > 65 years
  • WHO performance status 0-3 (see appendix D)
  • Measurable tumorparameter (M-protein or Bence Jones prote﮵ria)
  • Written informed consent.
Exclusion Criteria:
  • Known intolerance to Thalidomide
  • Systemic AL amyloidosis
  • Polyneuropathy
  • Severe cardiac dysfunction (NYHA classification II-IV, appendix E)
  • Severe pulmonary dysfunction
  • Significant hepatic dysfunction (total bilirubin >= 30 umol/l or transaminases >= 2.5 times normal level), unless related to myeloma
  • Renal failure with dependency on dialysis
  • Patients with active, uncontrolled infections
  • Pre-treatment with cytostatic drug or alpha interferon
  • Patients known to be HIV-positive
  • History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Participating Sites

Site
52 results
Order by
Accrual rate
Activation date
NL-Meppel-ISALADIACONESSEN
NL-Apeldoorn-GELREAPELDOORN
NL-Delfzijl-OMMELANDERDELFZIJL
NL-Den Haag-HMCBRONOVO
NL-Terneuzen-ZORGSAAM
NL-Den Haag-HMCWESTEINDE
NL-Leidschendam-HMCANTONIUSHOVE
NL-Dirksland-VANWEELBETHESDA
NL-Gouda-GROENEHART
NL-Roosendaal-BRAVIS
NL-Winterswijk-SKBWINTERSWIJK
NL-Groningen-MARTINI
NL-Zutphen-GELREZUTPHEN
NL-Haarlem-SPAARNEHAARLEM
NL-Hoogeveen-TRENTBETHESDA
NL-Assen-WZA
NL-Sittard-Geleen-ZUYDERLAND
NL-Leiderdorp-ALRIJNELEIDERDORP
NL-Utrecht-DIAKONESSENUTRECHT
NL-Rotterdam-SFG
NL-Emmen-SCHEPER
NL-Hengelo-ZGTHENGELO
NL-Roermond-LZR
NL-Sneek-ANTONIUSSNEEK
NL-Venlo-VIECURI
NL-Goes-ADRZ
NL-Delft-RDGG
NL-Amsterdam-OLVG
NL-Enschede-MST
NL-Amersfoort-MEANDERMC
NL-Eindhoven-MAXIMAMC
NL-Maastricht-MUMC
NL-Leiden-LUMC
NL-Den Bosch-JBZ
NL-Zwolle-ISALA
NL-Rotterdam-ERASMUSMC
NL-Rotterdam-EMCDANIEL
NL-Breda-AMPHIA
NL-Nijmegen-RADBOUDUMC
NL-Nieuwegein-ANTONIUS
NL-Leeuwarden-MCL
NL-Heerlen-ATRIUMMC
NL-Amstelveen-AMSTELLAND
NL-Schiedam-FRANCISCUSVLIETLAND
NL-Amsterdam-SLOTERVAART
NL-Rotterdam-MAASSTADZIEKENHUIS
NL-Dordrecht-ASZ
NL-Arnhem-RIJNSTATE
NL-Amsterdam-VUMC
NL-Utrecht-UMCUTRECHT
NL-Groningen-UMCG
NL-Amsterdam-AMC
= Active hospitals
= Inactive hospitals

Participating Parties

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