Recurrent Plasma Cell Myeloma Clinical Trial
Official title:
Overcoming Chemotherapy Resistance in Refractory Multiple Myeloma With Simvastatin, A Pilot Study
This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To examine the effect of simvastatin on myeloma (M)-protein and/or free light chains ratio
when added to conventional chemotherapy for the treatment of multiple myeloma patients who
have received up to 3 (=< 3) and > 3 different chemotherapy regimens. (group A and group B)
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS), time to progression (TTP), and duration
of response (DOR) in group A, group B, and both groups combined.
II. To describe toxicities (frequency and severity during the treatment) in group A, group B,
and both groups combined.
III. To estimate overall response (OR) in group A, group B, and both groups combined.
IV. To evaluate the quality of life (QoL) of patients on the combined treatment in group A,
group B, and both groups combined.
OUTLINE:
Patients receive standard of care chemotherapy for up to 3 courses and simvastatin orally
(PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose
of chemotherapy. Treatment with simvastatin continues in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3-5 weeks for
the first 6 months, and every 1-3 months thereafter.
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