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