PD-1 Blockade + Dendritic Cell Fusion Vaccine + CT-011 for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavid Avigan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Avigan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who are candidates for high-dose chemotherapy and stem cell rescue. They must have a certain level of heart function, specific lab results, measurable disease, and no serious illnesses like significant heart disease or active infections. Pregnant women or those with autoimmune diseases (except stable hypothyroidism) can't join.

Inclusion Criteria

Your heart's pumping ability is greater than 45%.

Your test results need to match the study's requirements.

Patients with multiple myeloma who may be considered for intensive chemotherapy followed by stem cell transplant.

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Exclusion Criteria

You have had a serious blood clot in a vein in the past.

You have a serious autoimmune disease.

You have HIV.

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Treatment Details

Interventions

CT-011 (Monoclonal Antibodies)
Dendritic Cell Fusion Vaccine (Cancer Vaccine)

Trial OverviewThe study is testing the safety and effect of CT-011 alone and combined with a dendritic cell fusion vaccine after autologous stem cell transplantation in multiple myeloma patients. It aims to see if this combination helps prevent or delay cancer recurrence better than standard therapy.

Participant Groups

2Treatment groups

Active Control

Group I: Group 1Active Control1 Intervention

Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals.

Group II: Group 2Active Control2 Interventions

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.