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NCT01179490 · OUTCOME

Response Rate (Based on the IMWG Criteria)

Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma · Source last updated 2013-03-18

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 36 weeks

What was measured

The proportion of subjects evaluated as response \[sCR + CR + very good partial response (VGPR) + Partial Response (PR)\] was calculated. VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to \<200mg per 24 h

Groups in this outcome

SyB L-0501 + Prednisolone

SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.

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

Analysis denominator · Participants

GroupSource count
SyB L-0501 + Prednisolone5

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone60.0Not reported14.794.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60.0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The proportion of subjects evaluated as response \[sCR + CR + very good partial response (VGPR) + Partial Response (PR)\] was calculated. VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to \<200mg per 24 h
dispersion Type
95% Confidence Interval
groups
  1. description
    SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
    id
    OG000
    title
    SyB L-0501 + Prednisolone
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 36 weeks
title
Response Rate (Based on the IMWG Criteria)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice