NCT01783522

Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib

A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Beth Faiman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapeutic Agent Toxicity
• Multiple Myeloma
• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	glutamine	Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
OTHER	quality-of-life assessment	Ancillary studies
OTHER	placebo	Given PO

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-02-05
• Last updated: 2019-10-22
• Results posted: 2019-10-22

Locations

1 site across 1 country: United States