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

Primary Purpose

Multiple Myeloma, Plasmocytoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
autologous idiotype-protein pulsed dendritic cells
Sponsored by
University Hospital Carl Gustav Carus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring dendritic cells (DC), idiotype (Id), immunotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • myeloma stages II-III
  • asecretory disease

Sites / Locations

  • University Hospital Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

s.c. vaccination

i.v. vaccination

Arm Description

vaccine given subcutaneously

vaccines are given intravenously

Outcomes

Primary Outcome Measures

Specific T-cell proliferation/cytokine secretion

Secondary Outcome Measures

number of T cells
monoclonal protein
plasmacells in bone marrow
vital signs

Full Information

First Posted
October 1, 2009
Last Updated
October 1, 2009
Sponsor
University Hospital Carl Gustav Carus
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1. Study Identification

Unique Protocol Identification Number
NCT00988312
Brief Title
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
Official Title
Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Carl Gustav Carus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasmocytoma
Keywords
dendritic cells (DC), idiotype (Id), immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
s.c. vaccination
Arm Type
Experimental
Arm Description
vaccine given subcutaneously
Arm Title
i.v. vaccination
Arm Type
Experimental
Arm Description
vaccines are given intravenously
Intervention Type
Biological
Intervention Name(s)
autologous idiotype-protein pulsed dendritic cells
Intervention Description
Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
Primary Outcome Measure Information:
Title
Specific T-cell proliferation/cytokine secretion
Secondary Outcome Measure Information:
Title
number of T cells
Time Frame
pre and post vaccination
Title
monoclonal protein
Time Frame
pre and post vaccination
Title
plasmacells in bone marrow
Time Frame
pre and post vaccination
Title
vital signs
Time Frame
pre and post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: multiple myeloma stage I (Salmon & Durie) no cytoreductive pre-treatment Exclusion Criteria: myeloma stages II-III asecretory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Gretzinger, MD
Organizational Affiliation
University Hospital Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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

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