Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Arsenic Trioxide; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Vincristine

Criteria

Inclusion Criteria:

• Must have Multiple Myeloma

• No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma

• ECOG performance status must be 0-2

Exclusion Criteria:

• Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan.

• QT interval ≥480 msec on baseline ECG.

• No history of cardiac disease.

• Pregnant or breast-feeding.

• No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil.

• History of prior or concurrent malignancy or myelodysplasia.