Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
David Avigan, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-Farber Cancer Institute/Brigham & Women's Hospital||Boston, Massachusetts 02115|