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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Rambam Health Care Campus |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00458653 |
The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.
Condition | Intervention | Phase |
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Multiple Myeloma |
Biological: Dendritic Cell Tumor Fusion |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma |
Estimated Enrollment: | 42 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Post-transplant vaccination
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Biological: Dendritic Cell Tumor Fusion
Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses. Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT |
Group B: Experimental
Pre- and post-transplant vaccination
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Biological: Dendritic Cell Tumor Fusion
Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses. Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Avigan, MD | 617-667-9920 | davigan@bidmc.harvard.edu |
Contact: Dilani Dombagoda | 617-667-5984 | ddombago@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: David Avigan, MD 617-667-9920 | |
Contact: Dilani Dombagoda 617-667-5984 ddombago@bidmc.harvard.edu | |
Sub-Investigator: Jacalyn Rosenblatt, MD | |
Sub-Investigator: James D Levine, MD | |
Sub-Investigator: Robin Joyce, MD | |
Sub-Investigator: Lynne Uhl, MD | |
Sub-Investigator: David McDermott, MD | |
Sub-Investigator: Jeffrey Zwicker, MD | |
Sub-Investigator: Dimitrios Tzachanis, MD | |
Sub-Investigator: Vassiliki Boussiotis, MD | |
Sub-Investigator: Richard Haspel, MD | |
Massachusetts General Hospital | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Bimalangshu Dey, MD 617-724-1124 bdey@partners.org | |
Contact: Joanne Kennedy, RN (617) 726-6034 jkennedy9@partners.org | |
Sub-Investigator: Thomas Spitzer, MD | |
Sub-Investigator: Karen Ballen, MD | |
Sub-Investigator: Eyal Attar, MD | |
Sub-Investigator: Steve McAfee, MD | |
Sub-Investigator: Yi-Ben Chen, MD | |
Dana-Farber Cancer Institute/Brigham & Women's Hospital | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Nikhil Munshi, MD 617-632-4166 nikhil_munshi@dfci.harvard.edu | |
Contact: Carolyn Revta 617-632-2365 carolyn_revta@dfci.harvard.edu | |
Sub-Investigator: Donald Kufe, MD | |
Sub-Investigator: Baldev Vasir, PhD | |
Sub-Investigator: Zekui Wu, MD | |
Sub-Investigator: Kenneth Anderson, MD | |
Sub-Investigator: Paul G Richardson, MD | |
Sub-Investigator: Robert Schlossman, MD | |
Sub-Investigator: Irene Ghobrial, MD | |
Sub-Investigator: Jacob Laubach, MD | |
Israel | |
Rambam Medical Center | Recruiting |
Haifa, Israel, 31096 | |
Contact: Irit Avivi, MD 97248543426 i_avivi@rambam.health.gov.il | |
Contact: Michal Tsumer 97248543426 m_tsumer@rambam.health.gov.il | |
Principal Investigator: Irit Avivi, MD | |
Sub-Investigator: Tamar Katz, MD | |
Sub-Investigator: Jacob M Rowe, MD | |
Sub-Investigator: Noam Benyamini, MD |
Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( David Avigan, MD ) |
Study ID Numbers: | 04-098 |
Study First Received: | April 10, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00458653 |
Health Authority: | United States: Food and Drug Administration |
DC/tumor cell fusions GM-CSF high dose chemotherapy |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |