sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 50 MM


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


return to top

News


No news


1. Overview



Summary

A randomized phase III study on the effect of Thalidomide combined with Adriamycin, Dexamethasone (AD) and High Dose Melphalan in patients with multiple myeloma


Status

closed



Type of study

Prospective randomized Phase III study


Target number of patients

450


Current number of patients

555


Date of activation

27-Nov-2001


Date closed

01-Jun-2005


Approved by

CKTO: CKTO 2001-02, 9 July 2001
MEC: METc UMCU, 30 July 2001


Change history / amendement

Amendment 1: 18 september 2001, approved 21 November 2001
Amendment 2: 8 January 2002, approved 5 February 2002
Amendment 3: 12 August 2003, approved 7 October 2003


2. Patient eligibility criteria



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 (see appendix D);
Negative pregnancy test at inclusion if applicable;
Written informed consent.


Exclusion criteria

Known intolerance of Thalidomide;
Systemic AL amyloidosis;
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 mumol/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 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 <= 55 years with an HLA-identical sibling who will undergo myeloablative AlloSCT.


3. Registration (& randomization) of patients



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
Institution name
Name of caller/responsible investigator
Patient�s initials or code
Patient�s hospital record number
Sex
Date of birth
Date of diagnosis of multiple myeloma
Eligibility criteria
Date of start treatment


4. Participating parties



Principal Investigator(s)

Prof. Dr. H.M. Lokhorst (VUMC)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Trial Manager(s)

Mw. H.A. Visser - Wisselaar (Erasmus MC - Daniel)


Other functions

Reviewer - Cytogenetics - Dhr. Dr. A. Buijs (UMCU)
Reviewer - Cytogenetics - Mw. A. Simons (Radboudumc)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)


Principal investigator

H.M. Lokhorst (H.Lokhorst@digd.azu.nl)


Coordinating investigator(s)

P. Sonneveld (p.sonneveld@erasmusmc.nl)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

H.A. Visser-Wisselaar (h.visser-wisselaar@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
13
NL-Amersfoort-Meander MC
17
NL-Amsterdam-AMC
33
NL-Amsterdam-Antoni van Leeuwenhoek ZH
3
NL-Amsterdam-OLVG
6
NL-Amsterdam-Slotervaart Ziekenhuis
3
NL-Amsterdam-VUMC
60
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
5
NL-Arnhem-Ziekenhuis Rijnstate
4
NL-Breda-Amphia ziekenhuis, locatie Langendijk
9
Show 37 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



return to top