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NCT02661022 · OUTCOME

Progression-free Survival

SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2024-04-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 Months

What was measured

Per International Myeloma Working Group Response Criteria, progression/progressive disease is defined as increase of \>25% from lowest response value in any 1 of the following: serum M-component (the absolute increase must be \>0.5 g/dL)4 and/or urine M-component (the absolute increase must be \>200 mg/24 h) and/or; only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL; only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels; bone marrow plasma cell percentage (absolute % must be ≥10%); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder.

Groups in this outcome

SL-401 7 µg/kg/Day

SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone

SL-401 9 µg/kg/Day

SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone

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

Analysis denominator · Participants

GroupSource count
SL-401 7 µg/kg/Day5
SL-401 9 µg/kg/Day1

Reported measurements

Disease Progression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Censored
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day4Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
PFS at 6 Months
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day4Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
PFS at 12 Months
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Disease Progression
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Death
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Censored
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    PFS at 6 Months
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    PFS at 12 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Per International Myeloma Working Group Response Criteria, progression/progressive disease is defined as increase of \>25% from lowest response value in any 1 of the following: serum M-component (the absolute increase must be \>0.5 g/dL)4 and/or urine M-component (the absolute increase must be \>200 mg/24 h) and/or; only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL; only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels; bone marrow plasma cell percentage (absolute % must be ≥10%); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder.
groups
  1. description
    SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
    id
    OG000
    title
    SL-401 7 µg/kg/Day
  2. description
    SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
    id
    OG001
    title
    SL-401 9 µg/kg/Day
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 12 Months
title
Progression-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice