A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
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|ClinicalTrials.gov Identifier: NCT00222105|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 1, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Doxil Drug: Thalidomide Drug: Dexamethasone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||July 2009|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222105
|Principal Investigator:||Delva Deauna-Limayo, MD||University of Kansas Medical Center|