Overview

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

Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beth Faiman
Collaborator:
National Cancer Institute (NCI)
Treatments:
Bortezomib
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