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

NCT ID: NCT00988312

Last Updated: 2009-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma Plasmocytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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s.c. vaccination

vaccine given subcutaneously

Group Type EXPERIMENTAL

autologous idiotype-protein pulsed dendritic cells

Intervention Type BIOLOGICAL

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

i.v. vaccination

vaccines are given intravenously

Group Type EXPERIMENTAL

autologous idiotype-protein pulsed dendritic cells

Intervention Type BIOLOGICAL

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

Interventions

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autologous idiotype-protein pulsed dendritic cells

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* myeloma stages II-III
* asecretory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Carl Gustav Carus

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Carl Gustav Carus

Principal Investigators

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Susanne Gretzinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dresden

Locations

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University Hospital Dresden

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MyelomVak

Identifier Type: -

Identifier Source: org_study_id

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