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NCT02186834 · OUTCOME

Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma · Source last updated 2023-01-04

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 24 months

What was measured

Determine the overall response rate per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): \>/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow.

Analysis population: All participants treated at recommended phase 2 dose, regardless of when they joined the study.

Groups in this outcome

Selinexor, Liposomal Doxorubicin and Dexamethasone

Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)

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

Analysis denominator · Participants

GroupSource count
Selinexor, Liposomal Doxorubicin and Dexamethasone14

Reported measurements

>/= Very Good Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone0Not reportedNot reportedNot reportedNot reported
>/= Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone1Not reportedNot reportedNot reportedNot reported
>/= Minimal Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    >/= Very Good Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    >/= Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    >/= Minimal Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Stable Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Determine the overall response rate per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): \>/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow.
groups
  1. description
    Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
    id
    OG000
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants treated at recommended phase 2 dose, regardless of when they joined the study.
reporting Status
POSTED
time Frame
Up to 24 months
title
Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice