Status:
COMPLETED
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 patie...
Detailed Description
This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00097981
Start Date
January 1 2005
End Date
October 1 2009
Last Update
April 7 2017
Active Locations (58)
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1
Fountain Valley, California, United States
2
Greenbrae, California, United States
3
La Verne, California, United States
4
Los Angeles, California, United States