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Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma

Stem cells are a special type of blood cell, which are able to grow and divide. Stem cells
are given to patients after high dose chemotherapy to help restore blood production and
immunity. For an autologous stem cell transplant, stem cells are collected from a patient
before they have chemotherapy, then they are "transplanted" back to the same patient after
treatment. Circulating blood contains a very small number of stem cells. It is often
necessary to use the drug NeupogenTM, by injection under the skin twice a day for three
days, before stem cells are collected to help move the stem cells out of the bone marrow and
into the circulating blood. When the stem cells are in the blood, they can be collected
more easily. The study drug pegfilgrastim is very similar to NeupogenTM, however, it is
longer lasting. Therefore, treatment can be given as a single injection rather than several
injections over many days.

For this study, you will receive a single injection of pegfilgrastim under the skin.
Starting 3 days after the injection, you will have blood tests (1-2 tablespoons) once a day.
These blood tests will be used to learn if there are enough stem cells circulating in the
blood to start the collection procedure and for tests to check for any side effects of the
drug. These once a day blood tests will continue up to 10 days after the completion of the
stem cell collection procedure. When the stem cell count reaches a certain level (usually 4
or 5 days after the injection), stem cell collection will be started and done once a day
until enough cells have been collected for transplantation.

Before the collection starts, you will have blood (1-2 tablespoons) and urine samples
collected for routine tests. You will also have a chest x-ray and an electrocardiogram (ECG
- a test that measures the electrical activity of the heart). These tests are being done to
make sure you can handle the collection process. You will then have a central venous line
(CVL) placed. For this procedure, you will have a catheter (small flexible tube) placed in
a large vein under the collar bone. The CVL will be used to collect the stem cells.

You will have your stem cells collected by a procedure called apheresis. This procedure is
similar to donating platelets in a blood bank. In this process blood is collected through
the CVL and is passed through a cell separator machine. White cells (that contain the stem
cells) are collected and frozen and the remaining blood is given back to you. During the
apheresis procedure blood is kept from clotting by a continuous injection of ACD-A (sodium
citrate solution). This may cause some loss of calcium from the blood. To help with this
side effect, a calcium containing solution is continuously injected during the process of
stem cell collection. The procedure takes around 4-6 hours. If sufficient numbers of stem
cells are not collected in a single procedure, the procedure is repeated until the required
number of stem cells can be collected. The maximum number of procedures will be 5. If
enough stem cells cannot be collected after 5 procedures you will be taken off the study and
your doctor will discuss other treatment options with you.

The stem cells that are collected will be "transplanted" back to you after you have
high-dose chemotherapy as part of your standard care.

This is an investigational study. Pegfilgrastim is FDA approved and is commercially
available. It is approved to increase white blood cell count after chemotherapy. However,
its use in the collection of stem cells for transplantation is experimental. Up to 48
participants will take part in this study. All will be enrolled at UTMDACC.

Inclusion Criteria:

1. 1. Age 18 years or older

2. Patients with multiple myeloma undergoing autologous peripheral blood stem cell
transplantation and PBPC cell collection without chemopriming.

3. Zubrod performance status < 3 (Appendix E)

4. Serum bilirubin < 1.5 times the upper limit of normal, serum SGOT and SGPT < 2 times
the upper limit of normal, serum creatinine < 2.0 mg/dl

5. WBC > 3,500/ul

6. Platelet count > 100,000/ul prior to first apheresis procedure

7. Patients should not have received prior chemotherapy. Only patients who have been
treated with thalidomide, bortezomib, +/- dexamethasone will be eligible.

8. Sufficient peripheral venous access or central venous catheter

9. Informed consent

Exclusion Criteria:

1. Serious intercurrent medical illness

2. History of bleeding disorders (except patients with treated, myeloma related bleeding

3. Untreated hypercoagulation abnormalities

4. Patients with prior history of pulmonary embolism, deep venous thrombosis requiring
anticoagulant therapy, or placement of a venous filter.

5. Untreated symptomatic cardiac disease defined as left ventricular EF of <40% and NYHA
functional class of > II (Appendix F)

6. Uncontrolled infection defined as fever or antibiotics within 72 hours of

7. History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli
derived proteins.

8. Palpable splenomegaly or craniocaudal spleen length greater than 12 cms

9. Pregnancy

10. Use of aspirin, ibuprofen containing products within 7 days of enrollment

11. History of uncontrolled autoimmune disorder

12. Sickle cell trait/sickle cell disease

13. Women who are lactating or breast feeding

14. 14. Patients with abnormal cytogenetics that may be secondary to myelodysplasia (-5,
-7 and 11q23 abnormalities) will be excluded

15. Peripheral vascular disease

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Efficacy of pegfilgrastim in mobilizing progenitor cells

Outcome Time Frame:

Baseline to 10 days after pegfilgrastim injection

Safety Issue:


Principal Investigator

Chitra Hosing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

April 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • PBSC mobilization
  • Pegfilgrastim
  • Neulasta
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



MD Anderson Cancer Center Houston, Texas  77030-4096