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| Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00186316 |
Purpose
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.
| Condition | Intervention | Phase |
|
Multiple Myeloma |
Biological: Idiotype-pulsed allogeneic dendritic cells |
Phase I Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
| Official Title: | A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2003 |
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
Eligibility
| Ages Eligible for Study: | 17 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:1. For specimen collection and idiotype protein development:
Karnofsky performance status of 70 or greater
2. For Vaccination:
Patients must provide signed, informed consent
. Donor Inclusion Criteria (allodonor is the same donor used for non-myeloablative transplant)
Must provide signed, informed consent Exclusion Criteria:Patient Exclusion Criteria
1. For specimen collection and idiotype protein development:
Subjects with prognosis < 6 months
2. For Vaccination:
Any patient on more than two of the following immunosuppressive agents or at a dose greater than that indicated for a single immunosuppressive agent:
i. Mycophenylate Mofetil (MMF)- no greater than 1000mg twice a day ii. Prednisone- no greater than .5mg/kg/day iii. Cyclosporine- no greater than 300mg/day iv. Tacrolimis (FK506)- no greater than 4mg/day
Contacts and Locations| United States, California | |||||
| Stanford University School of Medicine | |||||
| Stanford, California, United States, 94305 | |||||
| Stanford University |
| National Cancer Institute (NCI) |
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
| Study ID Numbers: | BMT155, BMT155, NCT00186316 |
| First Received: | September 13, 2005 |
| Last Updated: | May 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00186316 |
| Health Authority: | United States: Food and Drug Administration |
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