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NCT01832727 · OUTCOME

Kaplan-Meier Estimate for Time to Progression (TTP) as Assessed by Investigator During Phase 2

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2020-07-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 up to 14.1 months

What was measured

Time to progression (TTP) was defined as the number of months between the start of treatment to the first documentation of disease progression. Disease progression was determined using IMWG-URC as assessed by the investigator. The same censoring rules, except for death, as in analysis of PFS were applied in the calculation of TTP. Participants who died prior to progressive disease were censored at the date of last evaluable response assessment.

Analysis population: Safety population

Groups in this outcome

Phase 2 300 mg 2/7 Schedule

The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.

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

Analysis denominator · Participants

GroupSource count
Phase 2 300 mg 2/7 Schedule18

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 300 mg 2/7 Schedule12.2Not reported3.5NAnot enough events to calculate
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        not enough events to calculate
        group Id
        OG000
        lower Limit
        3.5
        upper Limit
        NA
        value
        12.2
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Time to progression (TTP) was defined as the number of months between the start of treatment to the first documentation of disease progression. Disease progression was determined using IMWG-URC as assessed by the investigator. The same censoring rules, except for death, as in analysis of PFS were applied in the calculation of TTP. Participants who died prior to progressive disease were censored at the date of last evaluable response assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
    id
    OG000
    title
    Phase 2 300 mg 2/7 Schedule
param Type
MEDIAN
population Description
Safety population
reporting Status
POSTED
time Frame
Day 1 up to 14.1 months
title
Kaplan-Meier Estimate for Time to Progression (TTP) as Assessed by Investigator During Phase 2
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice