A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Degree of Peripheral Neuropathy (PNP)
The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
at 4 months (after 4 courses)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|