Conditions: Chemotherapeutic Agent Toxicity Multiple Myeloma Peripheral Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: glutamine intervention 2: quality-of-life assessment intervention 3: placebo
Intervention descriptions: intervention 1: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. intervention 2: Ancillary studies intervention 3: Given PO

Protocol document: