HOVON HO24 MM

Gearchiveerd

Main info

Identificatie:
HO24 MM / OG 96-020
Sponsor:
HOVON
Age:
18-65
Stadium:
1st lijn
Included patients:
453
Active sites:
0
(of 39)
38 sites are pending
Title:

Myelo-Ablative Chemo-/ Radiotherapy and Autologous Stem Cell Transplantation as compared to only Chemotherapy in Patients with Multiple Myeloma: A Prospective Randomized Phase III Study.

Timeline

Scheduled
Actual
1995
15 nov.
Activated
2000
01 apr.
Closeout in Progress
2010
01 apr.
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Patients under 66 years of age with previously untreated Multiple Myeloma and patients who have received a maximum of two courses of melphalan, prednisone or VMCP may be included in the study.
  • The patient must give informed consent according to the rules of the hospital.
  • Inclusion Criteria for IFN maintenance and PBSCT or ABMT:
  • At least PR after induction.
  • WHO performance status 0-2.
  • Suitable peripheral stem of bone marrow graft.
  • No active infections.
  • Absence of severe cardiac, pulmonary, neurologic or psychiatric disease.
  • Serum creatinine, bilirubine and transaminases of less than 2.5 times the upper limit of normal values.
  • Platelet count > 50 x 109/l.
  • Absolute neutrophil count > 1 x 109/l.
  • Informed consent.
Exclusion Criteria:
  • Age above 65 years.
  • WHO performance status 4.
  • Severe cardiac, pulmonary, neurologic or metabolis disease.
  • Inadequate liver function.
  • Patients with prior malignancies, except non-melanoma skin tumors or stage 0 cervical carcinoma.
  • Patients with prior extensive radiotherapy involving the myelum.

Registration Details

Registration
Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top

Registration criteria
The following information will be requested:

  • Protocol number
  • Name of caller and/or physicisan in charge.
  • Institutions name.
  • Patients name, date of birth and sex.
  • Hospital record number.
  • Stage II or III.

Participating Sites

Site
38 results
Order by
Accrual rate
Activation date
NL-Utrecht-UMCUTRECHT
54
NL-Nijmegen-RADBOUDUMC
44
NL-Rotterdam-ERASMUSMC
44
NL-Groningen-UMCG
41
NL-Rotterdam-EMCDANIEL
39
BE-Leuven-UZLEUVEN
33
NL-Enschede-MST
26
NL-Leiden-LUMC
21
NL-Amsterdam-AMC
17
NL-Nieuwegein-ANTONIUS
16
NL-Den Haag-HAGA
13
NL-Amersfoort-MEANDERMC
12
NL-Leeuwarden-MCL
9
NL-Maastricht-MUMC
8
NL-Zwolle-ISALA
7
NL-Rotterdam-SFG
6
NL-Sittard-Geleen-ZUYDERLAND
6
NL-Rotterdam-MAASSTADZIEKENHUIS
5
NL-Amsterdam-AVL
5
NL-Den Bosch-JBZ
4
NL-Hilversum-TERGOOI
4
NL-Heerlen-ATRIUMMC
4
NL-Amsterdam-OLVG
4
NL-Haarlem-SPAARNEHAARLEM
4
NL-Purmerend-DIJKLANDERPURMEREND
3
NL-Geldrop-STANNA
3
NL-Schiedam-FRANCISCUSVLIETLAND
3
NL-Amsterdam-SLOTERVAART
3
NL-Roosendaal-BRAVIS
2
NL-Leiderdorp-ALRIJNELEIDERDORP
2
NL-Terneuzen-ZORGSAAM
1
NL-Spijkenisse-SPIJKENISSEMC
1
NL-Breda-AMPHIA
1
NL-Rotterdam-IKAZIA
1
NL-Gouda-GROENEHART
1
NL-Dordrecht-ASZ
1
NL-Utrecht-DIAKONESSENUTRECHT
1
NL-Woerden-ANTONIUSWOERDEN
1
= Active hospitals
= Inactive hospitals

Participating Parties

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