Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: August 21, 2009
Last verified: August 2009
Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell transplant will receive 6 vaccinations of donor derived dendritic cells combined with specific protein produced by multiple myeloma.
Biological: Idiotype-pulsed allogeneic dendritic cells
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Primary Outcome Measures:
- Patient will complete 4 vaccinations of monthly interval
Secondary Outcome Measures:
- Evaluation of immune response. Immune response analysis will be done on all patients who are enrolled in the study. Patients who completed a minimum of 4 vaccinations will be included in immune response.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2006 (Final data collection date for primary outcome measure)
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
|Ages Eligible for Study:
||17 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:1. For specimen collection and idiotype protein development:
Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant)
- Age >17 years
- HIV negative
- Must provide signed, informed consent
Exclusion Criteria:1. For specimen collection and idiotype protein development:
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186316
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
No publications provided
||Ronald Levy, Principal Investigator, Stanford University School of Medicine
History of Changes
|Other Study ID Numbers:
||BMT155, 79000, BMT155
|Study First Received:
||September 13, 2005
||August 21, 2009
||United States: Institutional Review Board
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Physiological Effects of Drugs