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NCT03687125 · OUTCOME

Phase 2: Objective Response Rate (ORR) Based on International Myeloma Working Group (IMWG) Response Criteria

Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18

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
at Day 100 post-autologous stem cell transplant (ASCT)

What was measured

ORR was defined as the participants with a complete response (CR) or very good partial response (VGPR) or partial response (PR) as determined by IMWG Response Criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to less than (\<) 10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum longest diameter; VGPR was defined as a \>90% reduction in serum IgM levels from baseline.

Analysis population: The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2. Hence, no efficacy analysis were analyzed or collected in this study.

Groups in this outcome

Tinostamustine 180 mg/m^2

Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.

Tinostamustine 220 mg/m^2

Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.

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

Analysis denominator · Participants

GroupSource count
Tinostamustine 180 mg/m^20
Tinostamustine 220 mg/m^20

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
ORR was defined as the participants with a complete response (CR) or very good partial response (VGPR) or partial response (PR) as determined by IMWG Response Criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to less than (\<) 10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum longest diameter; VGPR was defined as a \>90% reduction in serum IgM levels from baseline.
groups
  1. description
    Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
    id
    OG000
    title
    Tinostamustine 180 mg/m^2
  2. description
    Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
    id
    OG001
    title
    Tinostamustine 220 mg/m^2
population Description
The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2. Hence, no efficacy analysis were analyzed or collected in this study.
reporting Status
POSTED
time Frame
at Day 100 post-autologous stem cell transplant (ASCT)
title
Phase 2: Objective Response Rate (ORR) Based on International Myeloma Working Group (IMWG) Response Criteria
type
PRIMARY

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

Preserved source evidence · Not medical advice