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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Rambam Health Care Campus |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Post-transplant vaccination |
|
| Group B | Experimental | Pre- and post-transplant vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cell Tumor Fusion | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the toxicity associated with vaccination of multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusions in conjunction with high dose chemotherapy with stem cell rescue | 5 years | |
| To determine if vaccination with DC/tumor cell fusions results in clinical disease response in patients with evidence of residual disease post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Avigan, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute/Brigham & Women's Hospital |
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| OTHER |
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| 5 years |
| To determine the time to disease progression in this participant population. |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| Rambam Medical Center | Haifa | 31096 | Israel |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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