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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:April 2005
End Date:June 2019

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

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.

- 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.

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
We found this trial at
4
sites
Haifa, 31096
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Haifa,
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Boston, MA
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