The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Key facts

Study ID

NCT00459069

Run by

Beth Israel Deaconess Medical Center

People needed

18

Starts

2004-07-01

Expected to finish

2009-11-01

Last updated by the study team

2010-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
• Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
• 18 years of age or older
• ECOG Performance Status of 0-1 with a greater than nine week life expectancy
• > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
• Laboratory results within ranges outlined in protocol
• Negative pregnancy test and adequate contraception method(s) must be documented

You may not qualify if…

• History of clinically significant venous thromboembolism
• Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
• Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
• Clinically significant autoimmune disease
• HIV positive
• Serious intercurrent illness
• Taking systemic corticosteroids within 4 weeks of treatment with study drug

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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