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Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma

Phase 2
70 Years
Not Enrolling

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Trial Information

Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma

Patients in this study will have a catheter (a tube) placed in the vein below the
collarbone. Most of the drugs used in the study will be given through the catheter. Blood
stem cells will be collected through this tube also.

Before treatment starts, patients will have a complete physical exam, including blood and
urine tests. A dentist will perform a dental exam either at M.D. Anderson or elsewhere. A
chest x-ray and bone x-rays will be done. An EKG and a heart scan will be done to test
heart function. A breathing test will be done. Patients will also be screened for HIV and

Blood stem cells will be collected from patients when white blood cell counts are normal.
This will be after earlier chemotherapy or after a bone marrow growth factor (G-CSF) has
been given. Collecting stem cells takes about 3 hours. It takes from 1 to 6 sessions to
get the needed amount of cells. The process is called apheresis. A machine is attached to
the catheter, and blood is drawn. The machine removes the stem cells from the blood and the
blood is then returned to the body through the catheter. G-CSF is injected under the skin
twice a day during the time the stem cells are collected. The stem cells are stored frozen
and will be used later to help patients recover from the high-dose chemotherapy.

After stem cells are collected, patients will receive high-dose chemotherapy.
Cyclophosphamide is given over 2 hours on Days 1 - 3. Melphalan is given on Days 4 and 5.
Topotecan is given over 30 minutes on Days 1 - 5, right after cyclophosphamide or melphalan.
On Day 6, no drugs are given. On Day 7, some or all of the stem cells will be reinfused.
G-CSF will be given once a day until blood counts return to normal.

Patients must stay in the hospital for the high-dose drug treatment. The length of stay
will be about 3 weeks. Blood tests will be done daily while in hospital, then once a week
for the first month. A bone marrow sample will be taken on Day 30. Blood samples will be
taken 4 times in the first year and once a year after that. Thyroid gland tests and a bone
marrow test will be done once a year.

This is an investigational study. Cyclophosphamide, melphalan, and topotecan are approved
by the FDA. Their use together in this study is experimental. All participants will be
enrolled at UTMDACC.

Inclusion Criteria:

1. Patients with intermediate or high tumor mass multiple myeloma with responsive or
primary refractory disease; and patients with responsive or refractory relapse.

2. Physiological age
3. Zubrod performance status < 3.

4. Life expectancy greater than 12 weeks.

5. Left ventricular ejection fraction >/= 50%.

6. No uncontrolled arrythmias or symptomatic cardiac disease.

7. FEV1, FVC and DLCO >/= 50%.

8. No symptomatic pulmonary disease.

9. Serum creatinine < 1.5 mg/dL.

10. Serum bilirubin < 2x upper limit of normal.

11. No evidence of chronic or active hepatitis or cirrhosis.

12. Patient is not pregnant.

13. Patients or guardian able to sign informed consent.

14. No active CNS disease.

15. Platelet count > 100K.

Exclusion Criteria:

1) N/A

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Outcome Time Frame:

Within 180 days after treatment

Safety Issue:


Principal Investigator

Michelle Donato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2002

Completion Date:

May 2006

Related Keywords:

  • Myeloma
  • Myeloma
  • Topotecan
  • Hycamtin
  • Melphalan
  • Alkeran
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Stem Cell Harvest
  • Peripheral Blood Stem Cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



U.T. M.D. Anderson Cancer Center Houston, Texas  77030