This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
CR+nCR rate
Will be estimated with an exact 90% confidence interval.
Time frame: After 18 weeks (6 courses of treatment)
CR+nCR+PR rate
Will be estimated with an exact 90% confidence interval.
Time frame: After 18 weeks (6 courses of treatment)
Maximal response rate
Time frame: After 18 weeks (6 courses of treatment)
Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Toxicities will be tabulated by type and grade.
Time frame: Up to 5 years
Progression-free survival
Will be estimated using the Kaplan-Meier method.
Time frame: From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: From on-study date to the date of death, assessed up to 5 years
Changes in IL-6 and MIP-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).
Time frame: Baseline to up to day 2 of course 1
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