Multiple Myeloma Clinical Trial
Official title:
Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma
NCT number | NCT00458653 |
Other study ID # | 04-098 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 2005 |
Est. completion date | July 2020 |
Verified date | June 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 2020 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa | |
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Rambam Health Care Campus |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the toxicity associated with vaccination of multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue. | 5 years | ||
Secondary | To determine whether tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusions in conjunction with high dose chemotherapy with stem cell rescue | 5 years | ||
Secondary | To determine if vaccination with DC/tumor cell fusions results in clinical disease response in patients with evidence of residual disease post-transplant | 5 years | ||
Secondary | To determine the time to disease progression in this participant population. |
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