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

October 1, 2009 updated by: University Hospital Carl Gustav Carus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • University Hospital Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • myeloma stages II-III
  • asecretory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Specific T-cell proliferation/cytokine secretion

Secondary Outcome Measures

Outcome Measure
Time Frame
number of T cells
Time Frame: pre and post vaccination
pre and post vaccination
monoclonal protein
Time Frame: pre and post vaccination
pre and post vaccination
plasmacells in bone marrow
Time Frame: pre and post vaccination
pre and post vaccination
vital signs
Time Frame: pre and post vaccination
pre and post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Carl Gustav Carus

Investigators

  • Principal Investigator: Susanne Gretzinger, MD, University Hospital Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

February 1, 2004

Study Completion (ACTUAL)

March 1, 2004

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyelomVak

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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