Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
|DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma||Drug: Bortezomib Other: Laboratory Biomarker Analysis Drug: Pegylated Liposomal Doxorubicin Hydrochloride||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma|
- CR+nCR rate [ Time Frame: After 18 weeks (6 courses of treatment) ]Will be estimated with an exact 90% confidence interval.
- Changes in IL-6 and MIP-1 [ Time Frame: Baseline to up to day 2 of course 1 ]The association of response with pre-treatment characteristics such as cytogenetics and fluorescence in situ hybridization and with early changes in IL-6 and MIP-1 will be described by reporting response rates (and their confidence intervals) according to subgroup (e.g., response rates by age group; response rates by large/small change in IL-6 level).
- CR+nCR+PR rate [ Time Frame: After 18 weeks (6 courses of treatment) ]Will be estimated with an exact 90% confidence interval.
- Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]Toxicities will be tabulated by type and grade.
- Maximal response rate [ Time Frame: After 18 weeks (6 courses of treatment) ]
- Overall survival [ Time Frame: From on-study date to the date of death, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- Progression-free survival [ Time Frame: From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
|Actual Study Start Date:||June 15, 2004|
|Primary Completion Date:||October 31, 2006 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bortezomib and pegylated liposomal doxorubicin)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Pegylated Liposomal Doxorubicin Hydrochloride
I. To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
I. To evaluate the overall response rate, including patients with CR, nCR, and partial response (PR), of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the impact of therapy with the bortezomib/pegylated liposomal doxorubicin regimen on the ability to collect peripheral blood stem cells in those patients going on to subsequent autologous stem cell transplantation.
III. To evaluate the time to progression (TTP) in all patients receiving bortezomib/pegylated liposomal doxorubicin therapy, both those who go on to autologous stem cell transplantation and those who do not go on to transplantation.
IV. To evaluate the value of early changes in levels of serum interleukin 6 (IL-6) and macrophage inflammatory protein 1 alpha (MIP-1α) as predictors of response to bortezomib/pegylated liposomal doxorubicin.
V. To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity.
Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks for 2 years and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088855
Hide Study Locations
|United States, California|
|Palo Alto Medical Foundation-Camino Division|
|Mountain View, California, United States, 94040|
|United States, Delaware|
|Christiana Care Health System-Christiana Hospital|
|Newark, Delaware, United States, 19718|
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, D.C., District of Columbia, United States, 20007|
|MedStar Washington Hospital Center|
|Washington, D.C., District of Columbia, United States, 20010|
|United States, Florida|
|Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33308|
|Jupiter Medical Center|
|Jupiter, Florida, United States, 33458|
|Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|Florida Hospital Orlando|
|Orlando, Florida, United States, 32803|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Kansas|
|Kansas City NCI Community Oncology Research Program|
|Prairie Village, Kansas, United States, 66208|
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889-5600|
|United States, Minnesota|
|Minneapolis Veterans Medical Center|
|Minneapolis, Minnesota, United States, 55417|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Missouri Baptist Medical Center|
|Saint Louis, Missouri, United States, 63131|
|Center for Cancer Care and Research|
|Saint Louis, Missouri, United States, 63141|
|United States, New Hampshire|
|Rochester, New Hampshire, United States, 03867|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Novant Health Presbyterian Medical Center|
|Charlotte, North Carolina, United States, 28204|
|Lenoir Memorial Hospital|
|Kinston, North Carolina, United States, 28501|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, South Carolina|
|Greenville Health System Cancer Institute-Eastside|
|Greenville, South Carolina, United States, 29615|
|United States, Vermont|
|Central Vermont Medical Center/National Life Cancer Treatment|
|Berlin Corners, Vermont, United States, 05602|
|University of Vermont College of Medicine|
|Burlington, Vermont, United States, 05405|
|United States, Virginia|
|Danville Regional Medical Center|
|Danville, Virginia, United States, 24541|
|Principal Investigator:||Robert Orlowski||Alliance for Clinical Trials in Oncology|