Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
NCT01067287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-04-06
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.
Conditions
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
Sponsors & Collaborators
- collaborator OTHER
-
Brigham and Women's Hospital
collaborator OTHER -
Rambam Health Care Campus
collaborator OTHER -
Gateway for Cancer Research
collaborator OTHER -
United States Department of Defense
collaborator FED -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
David Avigan, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-31
- Primary Completion
- 2025-09-30
- Completion
- 2025-12-31
Countries
- United States
- Israel
Study Locations
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