Clinical trial NCT01783522: Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chemotherapeutic Agent Toxicity
Multiple Myeloma
Peripheral Neuropathy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-02-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Degree of Peripheral Neuropathy (PNP)
timeFrame: up to 4 months from start of study
Secondary outcomes:
measure: Adherence to Bortezomib Treatment
timeFrame: Up to 4 months
measure: RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])
timeFrame: up to 4 months from start of study
measure: Average Change in Quality of Life Scores From Baseline to End of Study
timeFrame: from baseline to end of study at 4 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Beth Faiman
role: PRINCIPAL_INVESTIGATOR
References: