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NCT02661022 · OUTCOME

Overall Response Rate

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

Overall response rate is defined as complete response + very good partial response + partial response and clinical benefit rate (CR + VGPR + PR + minimal response \[MR\]) based on International Myeloma Working Group-defined response criteria and the duration of response (DOR) in relapsed refractory multiple myeloma (RRMM) patients.

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

Overall Response Rate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day5Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Complete Response
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
Stringent Complete Response
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
Very Good Partial Response
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
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day5Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
Minimal Response
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
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SL-401 7 µg/kg/Day0Not reportedNot reportedNot reportedNot reported
SL-401 9 µg/kg/Day1Not reportedNot reportedNot reportedNot reported
Progressive Disease
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
Progressive Disease or Death After Overall Response
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
Censored
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Overall Response Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Stringent Complete Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Very Good Partial Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Partial Response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Minimal Response
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Stable Disease
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Progressive Disease
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Progressive Disease or Death After Overall Response
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Censored
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Overall response rate is defined as complete response + very good partial response + partial response and clinical benefit rate (CR + VGPR + PR + minimal response \[MR\]) based on International Myeloma Working Group-defined response criteria and the duration of response (DOR) in relapsed refractory multiple myeloma (RRMM) patients.
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
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice