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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00988312
Date of registration: 01/10/2009
Primary sponsor: University Hospital Carl Gustav Carus
Public title: Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
Scientific title: Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma
Date of first enrolment: March 2002
Target sample size: 9
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- multiple myeloma

- stage I (Salmon & Durie)

- no cytoreductive pre-treatment

Exclusion Criteria:

- myeloma stages II-III

- asecretory disease

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Myeloma
Biological: autologous idiotype-protein pulsed dendritic cells
Primary Outcome(s)
Specific T-cell proliferation/cytokine secretion [Time Frame: No]
Secondary Outcome(s)
monoclonal protein [Time Frame: pre and post vaccination]
number of T cells [Time Frame: pre and post vaccination]
plasmacells in bone marrow [Time Frame: pre and post vaccination]
vital signs [Time Frame: pre and post vaccination]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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