Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute; Gateway for Cancer Research; Rambam Health Care Campus; United States Department of Defense
• Treatments: Pidilizumab; Polystyrene sulfonic acid; Vaccines

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