Overview

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