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

Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01067287 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-061

 

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.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Nikhil Munshi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Muriel Gannon, 617-632-4597, mgannon@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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
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