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NCT01989598 · OUTCOME

PFS

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-03-02

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
Time from the date of start of treatment to the date of documented progression (based on IMWG criteria) or death, whichever occurs first, due to any cause, assessed every 4 weeks, an average of 9 months.

What was measured

Summarized for each cohort using the Kaplan-Meier method, from the date of start of treatment to the date of documented progression (based on IMWG criteria) or death due to any cause, assessed every 4 weeks

Analysis population: Note: 25 patients enrolled, however, one patient unevaluable was not included in analysis

Groups in this outcome

Treatment (Trametinib, Akt Inhibitor GSK2141795)

Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Trametinib: Given PO Uprosertib: Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Trametinib, Akt Inhibitor GSK2141795)24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Trametinib, Akt Inhibitor GSK2141795)1.8Not reported0.93.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        3.2
        value
        1.8
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Summarized for each cohort using the Kaplan-Meier method, from the date of start of treatment to the date of documented progression (based on IMWG criteria) or death due to any cause, assessed every 4 weeks
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Trametinib: Given PO Uprosertib: Given PO
    id
    OG000
    title
    Treatment (Trametinib, Akt Inhibitor GSK2141795)
param Type
MEDIAN
population Description
Note: 25 patients enrolled, however, one patient unevaluable was not included in analysis
reporting Status
POSTED
time Frame
Time from the date of start of treatment to the date of documented progression (based on IMWG criteria) or death, whichever occurs first, due to any cause, assessed every 4 weeks, an average of 9 months.
title
PFS
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice