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Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

This study has been completed.
Sponsor:
Information provided by:
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT00988312
First received: October 1, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 1, 2009
October 1, 2009
March 2002
February 2004   (final data collection date for primary outcome measure)
Specific T-cell proliferation/cytokine secretion [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • number of T cells [ Time Frame: pre and post vaccination ] [ Designated as safety issue: No ]
  • monoclonal protein [ Time Frame: pre and post vaccination ] [ Designated as safety issue: No ]
  • plasmacells in bone marrow [ Time Frame: pre and post vaccination ] [ Designated as safety issue: No ]
  • vital signs [ Time Frame: pre and post vaccination ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Plasmocytoma
Biological: autologous idiotype-protein pulsed dendritic cells
Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
  • Experimental: s.c. vaccination
    vaccine given subcutaneously
    Intervention: Biological: autologous idiotype-protein pulsed dendritic cells
  • Experimental: i.v. vaccination
    vaccines are given intravenously
    Intervention: Biological: autologous idiotype-protein pulsed dendritic cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
March 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • multiple myeloma
  • stage I (Salmon & Durie)
  • no cytoreductive pre-treatment

Exclusion Criteria:

  • myeloma stages II-III
  • asecretory disease
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00988312
MyelomVak
No
Susanne Gretzinger, University Hospital Carl Gustav Carus
University Hospital Carl Gustav Carus
Not Provided
Principal Investigator: Susanne Gretzinger, MD University Hospital Dresden
University Hospital Carl Gustav Carus
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP