Status:
COMPLETED
Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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%.
Detailed Description
Rationale: The chemotherapy combination of doxorubicin, vincristine and dexamethasone (DVd) has been used with some efficacy in patients with multiple myeloma. However, DVd's efficacy is primarily con...
Eligibility Criteria
Inclusion
- Must have Multiple Myeloma
- No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma
- ECOG performance status must be 0-2
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00201695
Start Date
July 1 2004
End Date
August 1 2008
Last Update
June 10 2015
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210