Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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 monotherapy.

Key facts

Study ID

NCT00103506

Run by

Janssen Research & Development, LLC

People needed

646

Starts

2004-12-01

Expected to finish

2014-06-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Surprise, Arizona, United States
• Study site — Berkeley, California, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Altanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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