A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
|Multiple Myeloma||Drug: Doxil Drug: Thalidomide Drug: Dexamethasone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life|
- Overall Response Rate [ Time Frame: At End of Cycle 1, 28 Days ]Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
- Toxicity [ Time Frame: End of study, up to 12 months ]Count of Participants with adverse events.
|Study Start Date:||November 2002|
|Study Completion Date:||July 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Doxil, Thalidomide, Dexamethasone
Doxil 40 mg/m2 IV day 1
Other Name: pegylated liposomal doxorubicinDrug: Thalidomide
50-100 mg day 1-28
Other Name: thalidomidDrug: Dexamethasone
Dexamethasone 40 mg day 1-4 and 15-18
Other Name: decadron
Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.
This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222105
|Principal Investigator:||Delva Deauna-Limayo, MD||University of Kansas Medical Center|