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

Last updated: October 3, 2019
Sponsor: Beth Faiman
Overall Status: Terminated

Phase

2

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT01783522
CASE2A10
NCI-2011-01866
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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) performancescale

Exclusion

Exclusion Criteria:

  • Concurrent use of thalidomide, vincristine, platinum compound, or other agent known tocause significant neuropathy (concurrent lenalidomide will be allowed)

  • Hospitalization with clinical evidence of active infections as manifested by recurrentfevers, positive blood culture results, or requiring intravenous antibiotic therapy

  • Inadequate liver and renal function with liver transaminases 3x the upper limit ofnormal

  • 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 historyof 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 andthe 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

Study Design

Total Participants: 9
Study Start date:
February 01, 2013
Estimated Completion Date:
November 30, 2013

Study 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.

Connect with a study center

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

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