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Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
This study has been terminated.
(Research Cancelled)
Sponsor:
Beth Faiman
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Beth Faiman, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01783522
First received: January 31, 2013
Last updated: December 10, 2013
Last verified: December 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Chemotherapeutic Agent Toxicity Multiple Myeloma Peripheral Neuropathy | Drug: glutamine Other: quality-of-life assessment Other: placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, 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 |
Resource links provided by NLM:
Further study details as provided by Beth Faiman, Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Degree of Peripheral Neuropathy (PNP) [ Time Frame: at 4 months (after 4 courses) ]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.
Secondary Outcome Measures:
- Adherence to bortezomib treatment [ Time Frame: At the end of every month (course) for 4 months ]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 ]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 ]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.
| Enrollment: | 9 |
| Study Start Date: | February 2013 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: glutamine
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
Ancillary studies
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
Ancillary studies
Other Name: quality of life assessment
Other: placebo
Given PO
Other Name: PLCB
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01783522
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783522
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Beth Faiman
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Beth Faiman | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Beth Faiman, Principal Investigator, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01783522 History of Changes |
| Other Study ID Numbers: |
CASE2A10 NCI-2011-01866 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| Study First Received: | January 31, 2013 |
| Last Updated: | December 10, 2013 |
Additional relevant MeSH terms:
|
Peripheral Nervous System Diseases Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neuromuscular Diseases Nervous System Diseases Bortezomib Antineoplastic Agents |
ClinicalTrials.gov processed this record on August 22, 2017