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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988312
First Posted: October 2, 2009
Last Update Posted: October 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Carl Gustav Carus
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Plasmocytoma Biological: autologous idiotype-protein pulsed dendritic cells Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • Specific T-cell proliferation/cytokine secretion

Secondary Outcome Measures:
  • number of T cells [ Time Frame: pre and post vaccination ]
  • monoclonal protein [ Time Frame: pre and post vaccination ]
  • plasmacells in bone marrow [ Time Frame: pre and post vaccination ]
  • vital signs [ Time Frame: pre and post vaccination ]

Enrollment: 9
Study Start Date: March 2002
Study Completion Date: March 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: s.c. vaccination
vaccine given subcutaneously
Biological: autologous idiotype-protein pulsed dendritic cells
Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
Experimental: i.v. vaccination
vaccines are given intravenously
Biological: autologous idiotype-protein pulsed dendritic cells
Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • myeloma stages II-III
  • asecretory disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988312


Locations
Germany
University Hospital Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
University Hospital Carl Gustav Carus
Investigators
Principal Investigator: Susanne Gretzinger, MD University Hospital Dresden
  More Information

Responsible Party: Susanne Gretzinger, University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT00988312     History of Changes
Other Study ID Numbers: MyelomVak
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: October 2, 2009
Last Verified: October 2009

Keywords provided by University Hospital Carl Gustav Carus:
dendritic cells (DC)
idiotype (Id)
immunotherapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs