Status:
COMPLETED
Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
Multiple Myeloma
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexametha...
Detailed Description
This is a randomized, open label study comparing the efficacy, clinical benefit, toxicity and safety of the combination of Vincristine, DOXIL® (doxorubicin HCl liposome injection), and Dexamethasone (...
Eligibility Criteria
Inclusion
- Untreated multiple myeloma requiring treatment
- Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2
- Must have measurable disease
- Left Ventricular Ejection Fraction (LVEF) \>= 50 % determined by Multiple Gated Acquisition Scan (MUGA)
- Karnofsky performance status of \>= 60%
- Adequate bone marrow, liver and renal function
- Disease-free from prior malignancies \>= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control.
Exclusion
- Life expectancy of \>= 3 months
- Pregnant or breast feeding
- History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure
- or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months
- Uncontrolled diabetes mellitus or systemic infection
- Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma
- Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent
- Prior chemotherapy to treat Multiple Myeloma
- Prior radiotherapy to an area greater than 1/3 of the skeleton
- Prior local radiotherapy within 1 week of treatment
- Any investigational agent within 30 days of the first dose of treatment
- Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00344422
Start Date
October 1 2000
End Date
June 1 2004
Last Update
June 10 2011
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