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NCT00988312 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00988312
Other study ID # MyelomVak
Secondary ID
Status Completed
Phase Phase 1
First received October 1, 2009
Last updated October 1, 2009
Start date March 2002
Est. completion date March 2004

Study information
Verified date October 2009
Source University Hospital Carl Gustav Carus
Contact n/a
Is FDA regulated No
Health authority Germany: not applicable since not necessary
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date March 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- multiple myeloma

- stage I (Salmon & Durie)

- no cytoreductive pre-treatment

Exclusion Criteria:

- myeloma stages II-III

- asecretory disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University Hospital Dresden Dresden

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Carl Gustav Carus

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Specific T-cell proliferation/cytokine secretion No
Secondary number of T cells pre and post vaccination No
Secondary monoclonal protein pre and post vaccination No
Secondary plasmacells in bone marrow pre and post vaccination No
Secondary vital signs pre and post vaccination Yes
See also
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1