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NCT01783522 · OUTCOME

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

Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib · Source last updated 2019-10-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
up to 4 months from start of study

What was measured

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.

Analysis population: Subject data not collected due to low accrual. Research cancelled

Groups in this outcome

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. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies

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. quality-of-life assessment: Ancillary studies placebo: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Preventative Nutritional Supplementation)0
Arm II (Placebo)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
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.
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. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Preventative Nutritional Supplementation)
  2. description
    Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. quality-of-life assessment: Ancillary studies placebo: Given PO
    id
    OG001
    title
    Arm II (Placebo)
population Description
Subject data not collected due to low accrual. Research cancelled
reporting Status
POSTED
time Frame
up to 4 months from start of study
title
RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice