Recurrent Plasma Cell Myeloma Clinical Trial
Official title:
A Phase 2 Study of AZD6244 in Multiple Myeloma
This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.
PRIMARY OBJECTIVES:
I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in
patients with relapsed or refractory multiple myeloma (MM).
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free
survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate
capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2.
OUTLINE:
Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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