DS Stage II Plasma Cell Myeloma Clinical Trial
Official title:
Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
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.
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