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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Specific T-cell proliferation/cytokine secretion [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Susanne Gretzinger, University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT00988312     History of Changes
Other Study ID Numbers: MyelomVak
Study First Received: October 1, 2009
Last Updated: October 1, 2009
Health Authority: Germany: not applicable since not necessary

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
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013