Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00968396|
Recruitment Status : Withdrawn
First Posted : August 31, 2009
Last Update Posted : April 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: Apheresis Procedure: Stem Cell Transplantation Drug: Melphalan||Phase 2|
Hide Detailed Description
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.
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.
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2015|
Experimental: Stem Cell Collection + Transplantation
Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1.
On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.
Procedure: Stem Cell Transplantation
Co-culture Stem Cell Infusion on Day 0.
100 mg/m^2 IV over 30 minutes daily on Days -2 and -1
Other Name: Alkeran
- Neutrophil Engraftment Rate [ Time Frame: 28 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968396
|Study Chair:||Yago Nieto, MD, PHD||UT MD Anderson Cancer Center|