Refractory Multiple Myeloma Clinical Trial
Official title:
Combination Pegylated Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma (PLD-BCD)
RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride
and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
killing the cells or by stopping them from dividing. Bortezomib may stop the growth of
cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood
flow to the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with
bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal
doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and
to see how well it works in treating patients with multiple myeloma
PRIMARY OBJECTIVES:
I. To determine efficacy of this novel combination in newly diagnosed patients with multiple
myeloma.
SECONDARY OBJECTIVES:
I. To determine the toxicity of this novel combination regimen in previously treated
patients and newly diagnosed patients with multiple myeloma.
OUTLINE:
Patients receive cyclophosphamide intravenously (IV) or orally (PO) over 1 hour, bortezomib
IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive
pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats
every 28 days for up to 4 courses in the absence of disease progression or unacceptable
toxicity.
After completion of treatment, patients are followed up every 3 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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