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

NCT ID: NCT01783522

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-11-30

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.

Conditions

Chemotherapeutic Agent Toxicity; Multiple Myeloma; Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I (preventative nutritional supplementation)

Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

glutamine

Intervention Type: DRUG

Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Arm II (placebo)

Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

Group Type: PLACEBO_COMPARATOR

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

placebo

Intervention Type: OTHER

Given PO

Interventions

glutamine

Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.

Intervention Type: DRUG

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

placebo

Given PO

Intervention Type: OTHER

Other Intervention Names

2-aminoglutaramic acid; Gln; glutamic acid 5-amide; L-glutamine; NutreStore; quality of life assessment; PLCB

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly
• No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2
• Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Exclusion Criteria

• Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed)
• Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy
• Inadequate liver and renal function with liver transaminases 3x the upper limit of normal
• Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min
• Uncontrolled congestive heart failure
• Uncontrolled mood disorders
• Fasting blood glucose >150mg/dL or blood sugar (non-fasting) >200mg/dL if no history of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation.
• Seizure disorder
• Monosodium glutamate (MSG) allergy or soy allergy
• Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion
• Uncorrected Vitamin B12 or folate deficiency on last evaluation.
• Use of over the counter (OTC) supplements other than one multivitamin tablet a day
• Women who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Beth Faiman

OTHER

Sponsor Role: lead

Responsible Party

Beth Faiman

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Beth Faiman

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2011-01866

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE2A10

Identifier Type: -

Identifier Source: org_study_id