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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01783522
• Other study ID #: CASE2A10
• Secondary ID: NCI-2011-01866
• Status: Terminated
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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
• placebo
Given PO

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Beth Faiman	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to Bortezomib Treatment	Adherence reported as a percentage based on number of doses of study drug taken divided by the expected number of doses of study drug expected to be taken for the study duration.	Up to 4 months
Secondary	RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])	RR (sCR+CR+VGPR+PR) according to uniform international response criteria and CBR (RR+MR according to modified EBMT criteria) will be assessed with SPEP, 24h UPEP, serum urine immunofixation, and serum free light chain assay at the start of each cycle and after completion of the 4th cycle.	up to 4 months from start of study
Secondary	Average Change in Quality of Life Scores From Baseline to End of Study	Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm	from baseline to end of study at 4 months