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

NCT01783522 | Terminated Phase 2 Results DMC

• 2 other identifiers: CASE2A10NCI-2011-01866
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapeutic Agent Toxicity; Multiple Myeloma; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Degree of Peripheral Neuropathy (PNP)

  The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.

  up to 4 months from start of study

Secondary Outcomes (3)

• Adherence to Bortezomib Treatment

  Up to 4 months

• RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])

  up to 4 months from start of study

• Average Change in Quality of Life Scores From Baseline to End of Study

  from baseline to end of study at 4 months

Study Arms (2)

Arm I (preventative nutritional supplementation)

EXPERIMENTAL

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

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

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: quality-of-life assessment; Other: placebo

Interventions

glutamine DRUG

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

Also known as: 2-aminoglutaramic acid, Gln, glutamic acid 5-amide, L-glutamine, NutreStore

Arm I (preventative nutritional supplementation)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (preventative nutritional supplementation); Arm II (placebo)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Faiman: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Limitations and Caveats

This study closed early with limited accrual. Because of this, we did not collect patient data for all of the outcomes.

Results Point of Contact

• Title: Dr. Beth Faiman
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

faimanb@ccf.org

216-444-3705

Study Officials

• Beth Faiman

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-07

Locations

US (1)