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

Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00988312
Enrollment
9
Registered
2009-10-02
Start date
2002-03-31
Completion date
2004-03-31
Last updated
2009-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Plasmocytoma

Keywords

dendritic cells (DC), idiotype (Id), immunotherapy

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.

Interventions

BIOLOGICALautologous idiotype-protein pulsed dendritic cells

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

Sponsors

University Hospital Carl Gustav Carus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* myeloma stages II-III * asecretory disease

Design outcomes

Primary

MeasureTime frame
Specific T-cell proliferation/cytokine secretion

Secondary

MeasureTime frame
number of T cellspre and post vaccination
monoclonal proteinpre and post vaccination
plasmacells in bone marrowpre and post vaccination
vital signspre and post vaccination

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026