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NCT01849848 · OUTCOME

Response Rate (CR+PR) Based on the Blade Criteria

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma · Source last updated 2015-02-06

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

Measure
NUMBER
Unit
percentage of paticipants
Interval / dispersion
95% Confidence Interval
Time frame
up to around 44 weeks

What was measured

The criteria for PR based on the Blade are shown below. PR requires 1. or all of the others: 1. Some, but not all, of the criteria for CR are fulfilled 2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks 3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \<200 mg, maintained for a minimum of 6 weeks 4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy 5. ≥50% reduction in the size of soft tissue plasmacytomas 6. No increase in size or number of lytic bone lesions

Groups in this outcome

SyB L-0501

SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

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-050117

Reported measurements

Source class 1
Values in percentage of paticipants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SyB L-05010Not reported0.019.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        19.5
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
The criteria for PR based on the Blade are shown below. PR requires 1. or all of the others: 1. Some, but not all, of the criteria for CR are fulfilled 2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks 3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \<200 mg, maintained for a minimum of 6 weeks 4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy 5. ≥50% reduction in the size of soft tissue plasmacytomas 6. No increase in size or number of lytic bone lesions
dispersion Type
95% Confidence Interval
groups
  1. description
    SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
    id
    OG000
    title
    SyB L-0501
param Type
NUMBER
reporting Status
POSTED
time Frame
up to around 44 weeks
title
Response Rate (CR+PR) Based on the Blade Criteria
type
SECONDARY
unit Of Measure
percentage of paticipants

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

Preserved source evidence · Not medical advice