World Health Organization site
Skip Navigation Links

Main
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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00988312
Date of registration: 01/10/2009
Prospective Registration: No
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
URL:  http://clinicaltrials.gov/show/NCT00988312
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Germany
Contacts
Name:     Susanne Gretzinger, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital Dresden
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
Plasmocytoma
Intervention(s)
Biological: autologous idiotype-protein pulsed dendritic cells
Primary Outcome(s)
Specific T-cell proliferation/cytokine secretion [Time Frame: No]
Secondary Outcome(s)
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]
monoclonal protein [Time Frame: pre and post vaccination]
Secondary ID(s)
MyelomVak
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history