A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Newly diagnosed multiple myeloma, Thalidomide, Dexamethasone, DOXIL, Pegylated liposomal hydrochloride doxorubicin injection
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Thalidomide + dexamethasone
Thalidomide + dexamethasone + DOXIL