Overview

TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma

Status:
Completed
Trial end date:
2006-05-19
Target enrollment:
0
Participant gender:
All
Summary
To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
SmithKline Beecham
Treatments:
Cyclophosphamide
Melphalan
Topotecan
Criteria
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