Clinical trial · Interventional
Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
NCT01783522CI-TRIAL-00041239terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research Cancelled
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glutamine | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (preventative nutritional supplementation)
- description
- Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: glutamine
- Other: quality-of-life assessment
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: quality-of-life assessment
- Other: placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.