Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
Chemotherapeutic Agent Toxicity
Other: quality-of-life assessment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|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|
- Degree of Peripheral Neuropathy (PNP) [ Time Frame: at 4 months (after 4 courses) ] [ Designated as safety issue: No ]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.
- Adherence to bortezomib treatment [ Time Frame: At the end of every month (course) for 4 months ] [ Designated as safety issue: No ]Adherence to bortezomib treatment will be assessed by comparing cumulative body surface area adjusted doses administered during the first 4 cycles between placebo and glutamine groups.
- RR (complete remission [sCR+CR+very good partial remission [VGPR]+partial remission [PR]) [ Time Frame: At the beginning of each month and at the end of month 4 ] [ Designated as safety issue: No ]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.
- Quality of life [ Time Frame: At baseline and at the end of month 4 ] [ Designated as safety issue: No ]Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) plus the 11-item neurotoxicity sub-scale (FACT/GOG-Ntx) at the start of each cycle and after completion of the 4th cycle. Higher scores represent better quality of life.
|Study Start Date:||February 2013|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I (preventative nutritional supplementation)
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
Other Names:Other: quality-of-life assessment
Other Name: quality of life assessment
Placebo Comparator: Arm II (placebo)
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 Name: quality of life assessmentOther: placebo
Other Name: PLCB
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783522
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Beth Faiman||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|