Main
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Note: This record shows only 22 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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00988312 |
Date of registration:
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01/10/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
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Scientific title:
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Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma |
Date of first enrolment:
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March 2002 |
Target sample size:
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9 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00988312 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Susanne Gretzinger, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Dresden |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Plasmocytoma
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Intervention(s)
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Biological: autologous idiotype-protein pulsed dendritic cells
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Primary Outcome(s)
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Specific T-cell proliferation/cytokine secretion
[Time Frame: No]
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Secondary Outcome(s)
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number of T cells
[Time Frame: pre and post vaccination]
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plasmacells in bone marrow
[Time Frame: pre and post vaccination]
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vital signs
[Time Frame: pre and post vaccination]
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monoclonal protein
[Time Frame: pre and post vaccination]
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Secondary ID(s)
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MyelomVak
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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