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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Rambam Health Care Campus | OTHER |
| Gateway for Cancer Research |
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The purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). We are also trying to find out what effect the combination has on the disease, including if it is more successful in preventing or delaying the disease from coming back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug given by infusion into a vein and are known to target specific cells (in this case, cells in the immune system). The dendritic cell fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals. |
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| Group 2 | Active Comparator | Vaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-011 | Drug | Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| First Stage: To explore immunological response to Pidilizumab (MDV9300) in the post-transplant period. | Immune response will be measured by assessing percentage of T cells that express IFNγ following ex-vivo exposure to tumor lysate, as determined by the ratio of the maximum IFNγ expression to the baseline level pre-transplantation. A threshold response of a 10 fold increase in T cells expressing IFNγ will be considered significant. In the pilot phase, summary statistics (mean, median, range, standard error) will be used to report immunologic response on the entire patient cohort. In order to increase precision and provide more information about the immunologic response, the original sample size of 10 patients for the pilot study was increased up to 20. With 20 patients on this stage, the 90% C.I. will be no wider than 39.7%. | 3 years |
| Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody Pidilizumab (MDV9300)and DC/myeloma fusion cells in conjunction with stem cell transplant. | Cellular immunity will be determined by measuring fold increase in IFNγ expression. The combination of vaccination and Pidilizumab (MDV9300) will be considered promising if the study shows evidence of at least 75% patients with >10-fold increase in IFNγ expression, and would not be considered promising if >10-fold increase is observed in 50% or less patients. With total n=25 patients, the combination will be considered promising for further study if 17 or more patients demonstrate significant immune response. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| First Stage: Secondary objective: To assess the toxicity associated with treating multiple myeloma patients with Pidilizumab (MDV9300)in the post-autologous transplant setting. | Toxicity will be monitored and will be summarized for each grade. | 3 years |
| Second Stage: To assess the toxicity associated with treating multiple myeloma patients with the combination with DC/myeloma fusion vaccine following autologous 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 | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C585832 | pidilizumab |
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| OTHER |
| United States Department of Defense | FED |
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| Dendritic Cell Fusion Vaccine | Biological | One week following each infusion of CT-011 |
|
Toxicity will be monitored and will be summarized for each grade. |
| 3 years |
| To correlate levels of circulating activated and regulatory T cells with immunologic response | Levels of circulating activated and regulatory T cells and CD14+PD-L1+ cells will be measured at pre-transplantation, post-transplantation and several times after Pidilizumab (MDV9300) with or without vaccination. We will measure the level and the ratio of activated T cells/regulatory T cells and CD14+PD-L1+ monocytes at each time point. We will evaluate the profile of the ratio across time, several possible metrics (fold-change among successive time point) will be explored to evaluate the trend in the ratio across time. The correlation between the ratio and immunologic response (fold increase in IFNγ expression) will be assessed and reported using Spearman rank correlation at each time for 10 and 25 patients from each stage and total 35 patients from the study, by treating all measurement as continuous variables. At post-transplant time points, we will also compare the ratio of activated T cells/regulatory T cells for patients with and without significance immunologic response. | 3 years |
| To define anti-tumor effects using serum markers, radiological studies, and time to disease progression. | The percent of patients achieving a complete response (CR) following completion of therapy, including those converting from PR to CR after immunotherapy, will be reported for the phase II trial with descriptive statistics. Time to disease progression will also be characterized for with Kaplan-Meier curves. | 3 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Rambam Medical Center | Haifa | Israel |
| 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 |