Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Chemotherapeutic Agent Toxicity, Multiple Myeloma, Peripheral Neuropathy
In brief
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
Key facts
- Study ID
- NCT01783522
- Run by
- Beth Faiman
- People needed
- 9
- Starts
- 2013-02-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2019-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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