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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 54 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

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1. Overview


Non myeloablative allogeneic stem cell transplantation following high dose therapy as part of first line therapy to induce graft versus myeloma for patients <= 65 years participating in the HOVON 50 study.



Study details

Type of study

Prospective Phase II study

Target number of patients


Date of activation


Date closed


Approved by

CKTO: CKTO 2002-06, 20 February 2003
MEC: METC UMCU 02/268-O, 4 March 2003

2. Patient eligibility criteria

Inclusion criteria

Age 18-65 years inclusive;
Included in the HOVON 50 MM study;
Patient has received 3 cycles of VAD or AD+Thalidomide, CAD and 1 cycle of high dose Melphalan with autologous stem cell reinfusion according to HOVON 50 MM protocol;
NMA allogeneic transplantation planned between 2 and 6 months after autologous stem cell reinfusion;
WHO performance status 0-2;
HLA-identical family donor;
Written informed consent.

Donor Eligibility Criteria:
HLA genotypically identical sibling;
Informed consent to undergo G-CSF administration and leukapheresis;
Adequate veins for leukapheresis or agrees to placement of central venous catheter;
Willing and able to undergo apheresis procedure according to institutional guidelines.

Exclusion criteria

Creatinin clearance < 50 ml/min;
Severe cardiac dysfunction (NYHA classification II-IV, see appendix D) ;
Significant hepatic dysfunction (serum bilirubin >= 30 micromol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
Patients known to be HIV-positive;
Patients with active, uncontrolled infections;
Progressive disease / relapse from CR / progression from MR or PR after HDM with autologous stem cell reinfusion according to HOVON 50 MM protocol.

Donor exclusion criteria:
Monozygotic identical twin;
Age less than 12 years;
Known allergy to G-CSF;
HIV positive;
Current serious systemic illness.

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
Patient study number in HOVON 50 MM
Date of autologous stem cell reinfusion after 1 cycle of HDM in HOVON 50 MM
Planned date of NMA Allo-SCT
Eligibility criteria

4. Participating parties

Principal investigator

H.M. Lokhorst (

Coordinating investigator(s)

J.M.J.M. Zijlmans (


B. van der Holt (

Other functions

Please contact monitors at

5. Participating sites

Included patients *
NL-Maastricht-AZ Maastricht
NL-Rotterdam-Erasmus MC - Daniel
NL-Utrecht-UMC Utrecht

* 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


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