Multiple Myeloma Clinical Trial
Official title:
A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy
PRIMARY OBJECTIVES:
I. Estimate the objective effect size of glutamine compared to placebo as a prophylactic
intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients
4 months after their first dose of study drug.
SECONDARY OBJECTIVES:
I. Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as
determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events
(CTCAE) v4.03 criteria.
II. Determine if glutamine may improve adherence to bortezomib therapy.
III. Assess response rate (RR) and clinical benefit response rate (CBR) according to uniform
international response criteria and modified European Group for Blood and Marrow
Transplantation (EBMT) criteria.
IV. Determine if glutamine may improve quality of life (QOL) at 4 months.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive glutamine orally (PO) twice daily (BID). Courses repeat every 28 days
for 4 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the
absence of disease progression or unacceptable toxicity.
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