Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma

NCT ID: NCT00458653

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2020-07-31

Brief Summary

The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.

Detailed Description

• The first group of participants on this study will receive up to 3 monthly doses of the study vaccine beginning about 1 month following the autologous transplant. If this is found to be safe, the next group will receive one additional study vaccine prior to the transplant and then up to 3 doses after the transplant.
• If the screening tests determine that the participant is eligible for the study, they will undergo dendritic cell collection by a procedure called leukapheresis. Leukapheresis involves the collection of white blood cells from the blood. Dendritic cells are grown from these white blood cells in the laboratory. Tumor cells will also be collected from the bone marrow through a bone marrow aspirate/biopsy.
• After cells have been collected for study vaccine generation, the participant may receive standard therapy to reduce the number of multiple myeloma cells in the body. The specific regimen will be determined by the participants multiple myeloma physician.
• The first group of patients will receive the study vaccine only after the transplant. If this is found safe then the second group will receive a single study vaccine prior to the transplant.
• Prior to the autologous stem cell transplant, we will harvest stem cells from the participants blood that will be used for the transplant later. G-CSF will be given as a daily injection beginning the day after the chemotherapy and GM-CSF injections will be started seven days after the chemotherapy. These injections will continue until after the stem cells are collected. Approximately 10 days after the chemotherapy, participants will undergo a leukapheresis procedure to collect the stem cells.
• Within a few weeks of successful stem cell collection, the participant will be admitted to the hospital for high dose chemotherapy with autologous stem cell transplantation.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Post-transplant vaccination

Group Type: EXPERIMENTAL

Dendritic Cell Tumor Fusion

Intervention Type: BIOLOGICAL

Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.

Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT

Group B

Pre- and post-transplant vaccination

Group Type: EXPERIMENTAL

Dendritic Cell Tumor Fusion

Intervention Type: BIOLOGICAL

Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.

Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT

Interventions

Dendritic Cell Tumor Fusion

Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.

Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with multiple myeloma who are potential candidates for high dose chemotherapy
• 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 greater than a nine week life expectancy
• Patients with > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
• Negative pregnancy test, and adequate contraception method
• DLCO (adjusted)> 50%
• Cardiac Ejection Fraction > 45%
• Laboratory values within the ranges outlined in the 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Avigan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Avigan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute/Brigham & Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Rambam Medical Center

Haifa, , Israel

Countries

United States; Israel

Other Identifiers

04-098

Identifier Type: -

Identifier Source: org_study_id