Clinical Trial: Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis

Brief Summary: The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.

Detailed Summary:

Stem cells are found in the bone marrow and bloodstream, and they rebuild blood, bone marrow, and the immune system. This study uses autologous stem cells, which are stem cells collected from your own blood. Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Granulocyte-colony stimulating factor (G-CSF) is designed to help the bone marrow to make more white blood cells. G-CSF is used in this study to help move your stem cells out of the bone marrow and into the bloodstream. If your doctor decides it is needed, you will also receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. This allows the stems cells to be collected. Researchers also want to learn how the dose of infused stem cells affects the levels of certain cytokines in your blood. Cytokines are proteins that can cause symptoms such as fatigue and fever.

Treatment Plan:

If you are found to be eligible to take part in this study, you will need to have a central venous catheter (CVC) placed. A CVC is a flexible sterile tube that will be placed into a large vein that runs under your collarbone. Having the CVC allows blood to be drawn and medications to be given more easily and with less discomfort. You will be asked to sign a separate consent form to have the CVC placed, and the procedure will be more fully explained to you at that time.

If your doctor decides it is needed, you will receive chemotherapy to help your blood stem cells move out of your bone marrow and into your blood. You will be asked to sign a separate consent form for this chemotherapy.

Starting on the day of the stem cell infusion, you will receive G-CSF by injection under your skin. You will have
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Mean Symptom Severity Scores: Differences in post transplant symptom burden as measured by MDASI scores [ Time Frame: Baseline up to 1 year post transplant ]

MD Anderson Symptom Inventory (MDASI) regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms (e.g., fatigue, worrying, attention) on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10).


Original Primary Outcome: The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. [ Time Frame: 8 Years ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. [ Time Frame: 8 Years ]
  • Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure. [ Time Frame: 8 Years ]


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: March 31, 2008
Date Started: March 2008
Date Completion:
Last Updated: January 21, 2016
Last Verified: January 2016