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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 54 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


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News


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1. Overview



Summary

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.


Status

closed



Type of study

Prospective Phase II study


Target number of patients

40


Date of activation

02-Jun-2003


Date closed

07-Nov-2006


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;
Pregnancy;
Known allergy to G-CSF;
HIV positive;
Current serious systemic illness.


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
Patientís initials or code
Patientís hospital record number
Sex
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 (H.Lokhorst@digd.azu.nl)


Coordinating investigator(s)

J.M.J.M. Zijlmans (j.zijlmans@erasmusmc.nl)


Statistician(s)

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


Trial manager

A.H.M. Ammerlaan (a.ammerlaan@erasmusmc.nl)


Central data management

A.H.M. Ammerlaan (a.ammerlaan@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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