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NCT01783522 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2019-10-22

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Degree of Peripheral Neuropathy (PNP)

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outcome · POSTED

Adherence to Bortezomib Treatment

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outcome · POSTED

RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])

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outcome · POSTED

Average Change in Quality of Life Scores From Baseline to End of Study

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: glutamine
    2. Other: quality-of-life assessment
    label
    Arm I (preventative nutritional supplementation)
    type
    EXPERIMENTAL
  2. description
    Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Other: quality-of-life assessment
    2. Other: placebo
    label
    Arm II (placebo)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (preventative nutritional supplementation)
    description
    Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
    name
    glutamine
    other Names
    1. 2-aminoglutaramic acid
    2. Gln
    3. glutamic acid 5-amide
    4. L-glutamine
    5. NutreStore
    type
    DRUG
  2. arm Group Labels
    1. Arm I (preventative nutritional supplementation)
    2. Arm II (placebo)
    description
    Ancillary studies
    name
    quality-of-life assessment
    other Names
    1. quality of life assessment
    type
    OTHER
  3. arm Group Labels
    1. Arm II (placebo)
    description
    Given PO
    name
    placebo
    other Names
    1. PLCB
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
PREVENTION
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Degree of Peripheral Neuropathy (PNP)
    time Frame
    up to 4 months from start of study
secondary Outcomes
  1. description
    Adherence reported as a percentage based on number of doses of study drug taken divided by the expected number of doses of study drug expected to be taken for the study duration.
    measure
    Adherence to Bortezomib Treatment
    time Frame
    Up to 4 months
  2. description
    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.
    measure
    RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])
    time Frame
    up to 4 months from start of study
  3. description
    Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm
    measure
    Average Change in Quality of Life Scores From Baseline to End of Study
    time Frame
    from baseline to end of study at 4 months
Full study description
brief 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
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 of study drug. 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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice