Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
I. To evaluate the complete response (CR) + near-complete response (nCR) rate of the
bortezomib /pegylated liposomal doxorubicin 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. Data for minor responses (MR) and stable
disease (SD), as well as progressive disease (PD) will be collected as well.
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. Data will also be collected about the
engraftment characteristics of those patients who undergo transplantation, including the
number of days to achieve an ANC of 500, a platelet count of 100,000, and packed red blood
cell and platelet transfusion independence.
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 IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated
doxorubicin HCl liposome 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.
Patients are followed every 6 weeks for 2 years and then every 6 months for up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete plus near-complete (CR + nCR) response rate
Evaluated using the criteria of Blade et al. with the additional category or near-CR as defined by Richardson et al. Estimated with an exact 90% confidence interval.
Cancer and Leukemia Group B
United States: Food and Drug Administration
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Cancer and Leukemia Group B||Chicago, Illinois 60606|