HOVON HO54

Archived

Main info

Identifier:
HOVON 54 MM
Sponsor:
HOVON
Included patients:
93
Active sites:
6
(of 6)
Title:

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.

Timeline

Scheduled
Actual
2003
02 Jun
Activated
2006
07 Nov
CloseoutInProgressLastPtOutActualStart
2016
07 Nov
Archived

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Objectives:

Eligibility

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.

Participating Sites

Site
6 results
Order by
Accrual rate
Activation date
NL-Utrecht-UMCUTRECHT
31
NL-Rotterdam-EMCDANIEL
19
NL-Nijmegen-RADBOUDUMC
19
NL-Amsterdam-VUMC
13
NL-Maastricht-MUMC
6
NL-Amsterdam-AMC
5
= Active hospitals
= Inactive hospitals

Participating Parties

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