Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
Official Summary
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.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 35 participants
Interventions
- DRUG: CT-011 — Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses
- BIOLOGICAL: Dendritic Cell Fusion Vaccine — One week following each infusion of CT-011
Primary Outcomes
- First Stage: To explore immunological response to Pidilizumab (MDV9300) in the post-transplant period. (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. (3 years)
Secondary Outcomes
- First Stage: Secondary objective: To assess the toxicity associated with treating multiple myeloma patients with Pidilizumab (MDV9300)in the post-autologous transplant setting. (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. (3 years)
- To correlate levels of circulating activated and regulatory T cells with immunologic response (3 years)
- To define anti-tumor effects using serum markers, radiological studies, and time to disease progression. (3 years)
Eligibility Criteria
Inclusion Criteria: * Patients with multiple myeloma who are potential candidates for high doses chemotherapy with stem cell rescue * Patients must not have active of history of autoimmune disorders/conditions including Type I diabetes, Type II diabetes, vitiligo or stable hypothyroidism will not be considered exclusion criteria * Patients with measurable disease as defined by a history of an elevated M component in plasma, urine, or free kappa/lambda light chains in the serum * 18 years of age or older * ECOG Performance Status of 0-1 with a greater than nine week life expectancy * \>20% bone marrow involvement in plasmacytoma amenable to resection under local anesthesia * Negative pregnancy test and adequate contraception method(s) * DLCO (adjusted) \> 50% * Cardiac Ejection Fraction \> 45% * Laboratory results as defined in protocol Exclusion Criteria: * History of clinically significant venous thromboembolism * Clinically significant autoimmune disease * HIV positive * Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure * Pregnant or lactating women * History of allogeneic bone marrow/stem cell transplant
Trial Locations
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- Dana-Farber Cancer Institute, Boston, Massachusetts, United States
- Rambam Medical Center, Haifa, Israel
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.