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

1. Overview
Study details
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


No news

1. Overview


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



Study details

Type of study

Prospective randomized Phase III study

Target number of patients


Current number of patients


Date of activation


Date closed


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


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...:

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
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)


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

Other functions

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

Principal investigator

H.M. Lokhorst (

Coordinating investigator(s)

P. Sonneveld (


B. van der Holt (

Trial manager

H.A. Visser-Wisselaar (

Other functions

Please contact monitors at

5. Participating sites

Included patients *
BE-Leuven-UZ Gasthuisberg
NL-Amersfoort-Meander MC
NL-Amsterdam-Antoni van Leeuwenhoek ZH
NL-Amsterdam-Slotervaart Ziekenhuis
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
NL-Arnhem-Ziekenhuis Rijnstate
NL-Breda-Amphia ziekenhuis, locatie Langendijk
Show 35 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


return to top