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Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts

Phase 2
18 Years
75 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts

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

Inclusion Criteria:

1. Patients with multiple myeloma who have relapsed after an autologous transplant or
with a chemosensitive relapse more than one year post initial therapy

2. Age 18 to 75 years

3. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias

4. FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease

5. Serum bilirubin
6. HIV-negative

7. Negative Beta HCG test in a woman with child bearing potential, defined as not
post-menopausal for 12 months or no previous surgical sterilization

8. Patient or guardian able to sign informed consent

9. Marrow-MSC Donor Requirements: patients must have a family member who is matched at
2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC

Exclusion Criteria:

1. International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5
mg/L and albumin >/= 3.5 g/dL)

2. Patients with an apheresis collection
3. A fully matched related donor

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neutrophil Engraftment Rate

Outcome Time Frame:

28 Days

Safety Issue:


Principal Investigator

Yago Nieto, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Ex-Vivo Depletion of Myeloma Cells
  • Peripheral Blood Progenitor Cell Grafts
  • PBPC
  • Stem Cell Transplant
  • Bone marrow stem cells
  • Melphalan
  • Alkeran
  • Apheresis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell