Multiple Myeloma Clinical Trial
Official title:
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
A transplant of one's own bone marrow stem cells is part of a standard treatment for MM.
Because MM comes from the bone marrow, stem-cell products from the bone marrow can have
tumor cells mixed in them when they are transplanted. This may cause the disease to return
after transplant. This study will learn about a method of cleaning, or "purging," the MM
tumor cells from the stem cells by using the bone marrow of a relative.
Study Drugs:
Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause
cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be given G-CSF twice a
day through a needle under the skin on Days 1-5 to move stem cells from out of the bone
marrow and into the blood.
You will receive melphalan through a needle in your vein over 30 minutes each time on the 2
days directly before you receive the stem cell transplant.
Stem Cell Collection, Purging, and Transplantation:
On Day 5, stem cell collection will begin. You will have a central venous catheter (CVC - a
sterile, flexible tube) placed into a vein in your chest while you are under local
anesthesia. Your doctor will explain this procedure to you in more detail, and you will be
required to sign a separate consent form for this procedure.
Blood will be removed from your body through the CVC and passed through a machine that
separates stem cells from the other cells. The stem cells will be frozen for storage, and
the blood will be returned to your body. This 3-hour process is called apheresis. This
process will be done 1 time a day for 1-6 days, or until enough stem cells are collected.
Your stem cells will be placed in a sterile container, where they will grow and multiply
with donated stem cells from a relative. If there are enough cells after 2 weeks, the cells
will be transplanted back into the body. If there are not enough cells after the 2 weeks of
growing with the donor's stem cells, they will be combined with a sample that was set aside
at your initial collection and then transplanted back into the body.
Study Visits:
One (1), 2, and 6 months after the transplant, blood (about 2 teaspoons) will be drawn for
routine tests and to check the status of the disease.
Six (6) months after the transplant, you will also have a bone marrow aspirate/biopsy to
check the status of the disease.
Length of Study:
You will remain on study until 12 months after the transplant. You will be taken off study
if the disease gets worse or needs further treatment.
End-of-Treatment Visit:
Twelve (12) months after the transplant, you will have your end-of-treatment visit. At this
time, the following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of
the disease.
- You will have a bone marrow aspirate/biopsy.
- You will have x-rays taken of your bones.
This is an investigational study. Melphalan is FDA approved and commercially available for
the treatment of MM. While receiving a stem-cell transplant is standard treatment for MM,
cleaning (purging) the stem-cell product is investigational.
Up to 25 recipients will take part in this study. All will be enrolled at M. D. Anderson
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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