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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Thalidomide

Criteria

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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