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A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chemotherapeutic Agent Toxicity, Multiple Myeloma, Peripheral Neuropathy

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Trial Information

A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients


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.

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.


Inclusion Criteria:



- Patients with a diagnosis of symptomatic multiple myeloma who have received less than
4 months of 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

- Pre-existing 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Degree of Peripheral Neuropathy (PNP)

Outcome Description:

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.

Outcome Time Frame:

at 4 months (after 4 courses)

Safety Issue:

No

Principal Investigator

Beth Faiman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE2A10

NCT ID:

NCT01783522

Start Date:

February 2013

Completion Date:

May 2014

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Multiple Myeloma
  • Peripheral Neuropathy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195