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

Beth Faiman

Status and phase: Terminated; Phase 2

Conditions: Chemotherapeutic Agent Toxicity; Peripheral Neuropathy; Multiple Myeloma

Treatments: Other: placebo; Other: quality-of-life assessment; Drug: glutamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01783522

NCI-2011-01866 (Registry Identifier)

CASE2A10

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Arm I (preventative nutritional supplementation)

Experimental group

Description:

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

Treatment:

Drug: glutamine

Other: quality-of-life assessment

Arm II (placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: quality-of-life assessment

Other: placebo