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

This study is currently recruiting participants.
Verified February 2013 by Case Comprehensive Cancer Center
Sponsor:
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: February 19, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Degree of Peripheral Neuropathy (PNP) [ Time Frame: at 4 months (after 4 courses) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: October 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:
  • 2-aminoglutaramic acid
  • Gln
  • glutamic acid 5-amide
  • L-glutamine
  • NutreStore
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.

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of symptomatic multiple myeloma who will receive bortezomib for the first time at a dose of 1.3mg/m^2 subcutaneously (SQ) days 1, 8, 15 and 21 of a 28 day cycle
  • 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 Cockroft-Gault < 30 mL/min
  • Uncontrolled congestive heart failure
  • Uncontrolled mood disorders
  • Uncontrolled diabetes with hemoglobin A1C (HgA1C) greater 7%
  • Seizure disorder
  • Monosodium glutamate (MSG) allergy
  • Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion
  • Vitamin B12 or folate deficiency
  • Use of over the counter (OTC) supplements other than one multivitamin tablet a day
  • Women who are pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783522

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Beth Faiman, MSN     216-445-3738     faimanb@ccf.org    
Principal Investigator: Beth Faiman            
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

No publications provided

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
Study First Received: January 31, 2013
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Multiple Myeloma
Neoplasms, Plasma Cell
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
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
Signs and Symptoms
Poisoning
Substance-Related Disorders
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013