Status:
COMPLETED
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE m...
Detailed Description
This is a randomized (study drug assigned by chance), parallel-group, open-label (all involved people know the identity of the intervention), multicenter study in 18 countries. A total of 646 patients...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study
- Patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m\^2) doxorubicin, DOXIL, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
- Must have normal cardiac function, as evidenced by a left LVEF within institutional normal limits.
Exclusion
- History of treatment with VELCADE or progressive disease while receiving an anthracycline-containing regimen
- No change in disease status during initial therapy
- No treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen
- Non-secretory disease
- Myocardial infarct within past 6 months
- No major surgery in past 30 days.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT00103506
Start Date
December 1 2004
End Date
June 1 2014
Last Update
October 19 2015
Active Locations (108)
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1
Alabaster, Alabama, United States
2
Surprise, Arizona, United States
3
Berkeley, California, United States
4
Loma Linda, California, United States