Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00523848|
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : September 17, 2013
Last Update Posted : February 23, 2017
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib Drug: pegylated liposomal doxorubicin hydrochloride Drug: thalidomide||Phase 2|
- To determine the overall response rate (complete response and partial response) in patients previously untreated stage I, II, or III multiple myeloma.
- To evaluate the complete response rate in patients treated with this regimen.
- To determine the time to disease progression from the start of this therapy in patients treated with this regimen.
OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease who continue to show response after completion of 6 courses may receive 2 additional courses for a total of 8 courses.
After completion of study treatment, patients are followed every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)|
|Study Start Date :||June 2006|
|Primary Completion Date :||September 2011|
|Study Completion Date :||October 2012|
U.S. FDA Resources
Experimental: Arm 1
Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
IVDrug: pegylated liposomal doxorubicin hydrochloride
- Overall Response Rate (Complete and Partial) [ Time Frame: Every 3 months ]
- Complete Response Rate [ Time Frame: Every 3 months ]
- Time to Disease Progression [ Time Frame: Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523848
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Kelvin Lee, MD||Roswell Park Cancer Institute|