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

NCT01067287 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 09-061
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 3

Brief 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

Multiple Myeloma

Keywords

dendritic cell fusion vaccine; CT-011; autologous stem cell transplant

Outcome Measures

Primary Outcomes (2)

• First Stage: To explore immunological response to CT-011 in the post transplant period.

  3 years

• Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody CT-011 and DC/myeloma fusion cells in conjunction with stem cell transplant.

  3 years

Secondary Outcomes (4)

• First Stage: To assess the toxicity associated with treating multiple myeloma patients with CT-011 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

• Second Stage: To correlate levels of circulating activated and regulatory T cells with immunologic response

  3 years

• Second Stage: To define anti-tumor effects using serum markers, radiological studies, and time to progression.

  3 years

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Drug: CT-011

Group 2

ACTIVE COMPARATOR

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.

Drug: CT-011; Biological: Dendritic Cell Fusion Vaccine

Interventions

CT-011 DRUG

Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses

Group 1; Group 2

Dendritic Cell Fusion Vaccine BIOLOGICAL

One week following each infusion of CT-011

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma who are potential candidates for high doses chemotherapy with stem cell rescue

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Rambam Health Care Campus: collaborator
• Gateway for Cancer Research: collaborator
• United States Department of Defense: collaborator

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pidilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: February 11, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (2); IL (1)