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NCT01989598 · OUTCOME

ORR Evidenced by Confirmed Response Rate, Defined as Number of Patients With Partial Response or Better by International Myeloma Working Group (IMWG) Criteria Divided by the Number of Patients in the Applicable Group (Biomarker Positive or Negative)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Every 4 weeks until progression or death, whichever occurs first, an average of 9 months.

What was measured

"Per International Myeloma Working Group (IMWG) Criteria: Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Partial Response (PR), \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h; Overall Response (OR) = CR + PR."

Groups in this outcome

Treatment (Trametinib)

Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment (Trametinib, Akt Inhibitor GSK2141795)

Patients who develop progressive disease on trametinib monotherapy or achieve less then a PR after 4 cycles of treatment will have the option to continue on trametinib with the addition of GSK2141795

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)24
Treatment (Trametinib, Akt Inhibitor GSK2141795)11

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Trametinib)1Not reportedNot reportedNot reportedNot reported
Treatment (Trametinib, Akt Inhibitor GSK2141795)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      11
    units
    Participants
description
"Per International Myeloma Working Group (IMWG) Criteria: Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Partial Response (PR), \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h; Overall Response (OR) = CR + PR."
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.
    id
    OG000
    title
    Treatment (Trametinib)
  2. description
    Patients who develop progressive disease on trametinib monotherapy or achieve less then a PR after 4 cycles of treatment will have the option to continue on trametinib with the addition of GSK2141795
    id
    OG001
    title
    Treatment (Trametinib, Akt Inhibitor GSK2141795)
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 4 weeks until progression or death, whichever occurs first, an average of 9 months.
title
ORR Evidenced by Confirmed Response Rate, Defined as Number of Patients With Partial Response or Better by International Myeloma Working Group (IMWG) Criteria Divided by the Number of Patients in the Applicable Group (Biomarker Positive or Negative)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice