A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

Key facts

Study ID

NCT00097981

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

225

Starts

2005-01-01

Expected to finish

2009-10-01

Last updated by the study team

2017-04-07

Who can join

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

You may qualify if…

• Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group [IMWG] criteria
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Adequate absolute neutrophil count (ANC), platelet count and hemoglobin
• Adequate serum calcium
• Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)

You may not qualify if…

• No treatment with dexamethasone for multiple myeloma
• No peripheral neuropathy of Grade 2 or higher
• No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage
• No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study
• No deep vein thrombosis (DVT) within 1 year of enrollment
• No current anticoagulation for DVT

Where it is running

• Study site — Greenbrae, California, United States
• Study site — La Verne, California, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — New London, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Bethesda, Maryland, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Englewood, New Jersey, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Jersey City, New Jersey, United States
• Study site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.