HOVON HO65 MM

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Main info

Identificatie:
HO65 MM
Sponsor:
HOVON
Working group party:
Myeloma
Age:
18-65
Stadium:
1st lijn
Included patients:
833
(of 833)
Active sites:
82
(of 76)
Title:

A randomized phase III study on the effect of Bortezomib combined with Adriamycin, Dexamethasone (AD) for induction treatment, followed by High Dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma

Timeline

Scheduled
Actual
2005
31 mrt.
Opportunity
2005
22 apr.
Activated
2005
22 apr.
EC Approval
2008
16 mei
ClosedForInclusionActualStart
2019
16 dec.
Closeout in Progress
2021
11 mrt.
Archived

News

This study has been closed for further inclusion on 16may08.

Flow

Flow

Details

Phase:
Prospective Phase III study
Monitoring Type:
Study Specific
Objectives:
  • To assess the efficacy of Bortezomib combined with intensive chemotherapy and in maintenance therapy in comparison with intensive therapy with Vincristine followed by thalidomide maintenance in patients with previously untreated multiple myeloma, as measured by the progression free survival as defined in chapter 14.
  • To evaluate the overall response rate and CR + VGPR (complete and very good partial response) both after induction therapy and after autologous transplant.
  • To evaluate overall survival.
  • To assess the safety and toxicity of Bortezomib combined with intensive chemotherapy and in maintenance therapy.
  • To assess the prognostic value of risk factors at diagnosis, including β2-microglobulin, karyotypic abnormalities of chromosomes 9, 11 and 13 as analyzed in bone marrow plasma cells by karyotyping and FISH, with respect to progression free survival.
  • To analyze the prognostic value of myeloma gene expression profiles on the overall response on induction of all patients and of patients treated with Bortezomib separately.

Eligibility

Inclusion Criteria:
  • Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix A);
  • Age 18-65 years inclusive;
  • WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) (see appendix D);
  • Negative pregnancy test at inclusion if applicable;
  • Written informed consent.
Exclusion Criteria:
  • Known intolerance of Thalidomide or Boron;
  • Systemic AL amyloidosis;
  • Non-secretory MM
  • Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;
  • Severe cardiac dysfunction (NYHA classification II-IV, see appendix E);
  • Significant hepatic dysfunction (serum bilirubin ≥ 30 μmol/l or transaminases ≥ 2.5 times normal level), unless related to myeloma;
  • Patients known to be HIV-positive;
  • Patients with active, uncontrolled infections;
  • Patients with neuropathy, CTC grade 2 or higher
  • Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
  • Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
  • Patients ≤ 65 years with an HLA-identical sibling who will undergo non-myeloablative AlloSCT;
  • Lactating women.

Registration Details

The patient should be registered immediately after diagnosis, and before the start of chemotherapy. Patients need to be registered at the HOVON Data Center of the Erasmus MC Rotterdam – location Daniel by phone call: +31.10.4391568 or fax +31.10.4391028 Monday through Friday, from 09:00 to 17:00 or via the Internet via TOP (Trial Online Process; http://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.

The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Patient’s initials or code
  • Patient’s hospital record number (not obligatory)
  • Sex
  • Date of birth
  • Serum β2-microglobulin value
  • Serum albumin value
  • Eligibility criteria

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
82 results
Order by
Accrual rate
Activation date
DE-Heidelberg-UNIHEIDELBERG
134
03 jun. 2005
NL-Rotterdam-ERASMUSMC
76
04 mei 2005
NL-Amsterdam-VUMC
46
27 jun. 2005
DE-Hamburg-ASKLEPIOS
38
31 mei 2005
NL-Groningen-UMCG
33
22 sep. 2005
NL-Amsterdam-AMC
30
04 aug. 2005
NL-Utrecht-UMCUTRECHT
29
20 jun. 2005
DE-Berlin-CAMPUSBENFRANKLIN
27
22 sep. 2005
DE-Tübingen-MEDUNITUEBINGEN
20
18 dec. 2006
DE-Homburg-UNIKLINIKSAARLAND
19
09 dec. 2005
DE-Köln-UKKOELN
18
28 apr. 2006
NL-Nijmegen-RADBOUDUMC
18
04 jan. 2006
NL-Amersfoort-MEANDERMC
16
15 feb. 2006
DE-Essen-UKESSEN
14
10 nov. 2005
NL-Enschede-MST
14
10 aug. 2005
NL-Den Haag-HAGA
14
13 jun. 2005
DE-Hagen-KKH
11
28 mrt. 2006
NL-Zwolle-ISALA
11
13 feb. 2006
DE-Bonn-MEDUKLBONN
10
06 mrt. 2007
NL-Dordrecht-ASZ
10
03 okt. 2005
NL-Gouda-GROENEHART
10
12 apr. 2006
NL-Maastricht-MUMC
10
22 dec. 2006
DE-Cottbus-CTK
9
03 mrt. 2006
NL-Den Bosch-JBZ
9
15 jun. 2006
NL-Leiden-LUMC
9
23 mei 2006
DE-Bochum-RUB
8
26 mei 2006
DE-Frankfurt-KLINIKUMFRANKFURT
8
19 mei 2006
DE-Chemnitz-KLINIKUMCHEMNITZ
8
05 apr. 2007
DE-Frankfurt am Main-KGU
8
15 dec. 2005
NL-Utrecht-DIAKONESSENUTRECHT
8
26 sep. 2005
NL-Amsterdam-OLVG
8
11 nov. 2005
NL-Heerlen-ATRIUMMC
8
18 jan. 2006
NL-Leeuwarden-MCL
8
10 jan. 2006
DE-Monchengladbach-MARIAHILF
7
22 aug. 2006
NL-Nieuwegein-ANTONIUS
7
27 jun. 2005
NL-Leidschendam-HMCANTONIUSHOVE
7
13 jun. 2006
NL-Delft-RDGG
7
17 aug. 2005
DE-Ludwigshafen-KLILU
7
26 jan. 2006
DE-Essen-KEM
7
29 sep. 2006
DE-Hamm-EVKHAMM
6
15 mei 2006
NL-Roosendaal-BRAVIS
6
DE-Stuttgart-RBK
5
20 jul. 2006
DE-Bielefeld-KLINIKUMBIELEFELD
5
27 jan. 2006
NL-Winterswijk-SKBWINTERSWIJK
4
29 dec. 2005
NL-Breda-AMPHIA
4
06 jul. 2006
DE-Minden-MUEHLENKREISKLINKEN
4
30 mei 2006
BE-Leuven-UZLEUVEN
4
29 jan. 2008
NL-Rotterdam-MAASSTADZIEKENHUIS
4
22 mei 2006
NL-Nijmegen-CWZ
3
16 jun. 2006
NL-Arnhem-RIJNSTATE
3
06 okt. 2006
DE-München-SCHWABING
3
10 sep. 2007
DE-Marburg-PHILIPPS
3
26 okt. 2006
DE-Lübeck-SANALUEBECK
3
16 mrt. 2007
DE-Kaiserslautern-WESTPFALZ
3
19 mei 2006
NL-Amsterdam-AVL
3
14 mrt. 2006
DE-Bayreuth-KLINIKUMBAYREUTH
2
30 mei 2006
NL-Roermond-LZR
2
09 aug. 2007
DE-Lemgo-KLINIKUMLIPPE
2
30 mei 2006
NL-Den Haag-HMCBRONOVO
2
11 apr. 2006
DE-Schwabisch Hall-DASDIAK
2
19 jul. 2007
NL-Hilversum-TERGOOI
2
24 jul. 2007
NL-Apeldoorn-GELREAPELDOORN
2
08 jun. 2006
DE-Siegen-MARIEN
2
13 apr. 2006
BE-Antwerpen-ZNASTUIVENBERG
2
22 feb. 2008
NL-Den Haag-HMCWESTEINDE
2
06 dec. 2007
DE-München-HERLACHING
1
10 mrt. 2008
DE-Idar-Oberstein-IOSHG
1
06 jul. 2007
DE-Dessau-KLINIKUMDESSAU
1
06 jul. 2006
NL-Drachten-NIJSMELLINGHE
1
22 jun. 2006
NL-Zutphen-GELREZUTPHEN
1
06 apr. 2007
DE-Hannover-SILOAHKRH
1
10 mrt. 2008
DE-Osnabrueck-PARACELSUS
1
04 okt. 2007
DE-Frankfurt am Main-ONKOBETHANIEN
1
03 nov. 2005
NL-Schiedam-FRANCISCUSVLIETLAND
22 jan. 2008
BE-Antwerpen-ZNAMIDDELHEIM
DE-Bonn-UNIBONN
06 dec. 2006
BE-Hasselt-VIRGAJESSE
14 mrt. 2008
NL-Goes-ADRZ
NL-Deventer-DZ
18 dec. 2007
NL-Tilburg-ETZ
BE-Bonheiden-IMELDA
25 mrt. 2008
NL-Rotterdam-SFG
= Active hospitals
= Inactive hospitals

Participating Parties

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