The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
- To create the study vaccine, cells will be removed from the participants tumor and
fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained
from the participants blood.
- Not everyone who participates in this study will be receiving the same amount of study
vaccine. A small group of people will be enrolled into the study and given a certain
dose. If they tolerate it well, the next group of people enrolled will receive a
higher dose. This will continue until the highest dose level tolerated is determined.
- Once the screening tests are completed and it is determined the participant is
eligible, they will undergo some baseline procedures. In an effort to make the study
vaccine, tumor cells and dendritic cells will be collected from the participant. Tumor
cells may be collected from bone marrow or from a collection of tumor cells called a
plasmacytoma. A decision will be made based upon the location of the cancer.
- A bone marrow aspiration/biopsy will be performed during the following time points: at
screening, prior to the first vaccination, and at 1 month, 3 months, and 6 months after
the final study vaccination. These will be used to assess and follow the participants
- Leukapheresis will be performed to obtain dendritic cells. This procedure takes 2 to 4
hours to and involves the collection of a large number of white blood cells. Dendritic
cells will be generated in the laboratory from white blood cells. If not enough white
blood cells are collected, the participant may be asked to return to the clinic for an
additional leukapheresis procedure.
- Before each vaccine is administered (weeks 0, 3, 6) the following study tests and
procedures will be performed: skin test; blood test, physical exam and 24-hour urine
collection. A physical exam and blood tests will be performed on the weeks when the
participant does not receive the vaccine (weeks 1,2,4,5,7,8).
- The study schedule will consist of a fixed dose of the fused (mixed) cell vaccine under
the skin every 3 weeks. Each study vaccine will be accompanied by an injection of
GM-CSF. Participants will receive 2 or more vaccines depending upon the total number
of fusion cells made, the dose the participant is assigned to receive and their
response to the study vaccine.
- Follow-up after the vaccine treatment is completed will consist of the following:
blood collection (1, 3 and 6 months after final study vaccination); bone marrow
aspiration/biopsy (1, 3 and 6 months after final study vaccination); physical exam (1,
2, 3, 4, 5 and 6 months after final study vaccination); radiologic tumor assessment (1,
3 and 6 months after final study vaccination.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF.
David Avigan, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
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