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NCT02186834 · OUTCOME

Maximum Tolerated Dose (MTD)

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
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
Up to 12 months

What was measured

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D): Selinexor on Days 1, 8 and 15 when given in combination with Lipodox 20 mg/m\^2 and Dexamethasone 40 mg. Dose level 1: 40 mg in combination with Lipodox and Dexamethasone. Dose level 2: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone. Dose level 2m: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone. Dose level 3m: 80 mg (D1,3,8,10) in combination with Lipodox and Dexamethasone.

Analysis population: All participants treated during dose escalation

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 Dexamethasone19

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Liposomal Doxorubicin and Dexamethasone80Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D): Selinexor on Days 1, 8 and 15 when given in combination with Lipodox 20 mg/m\^2 and Dexamethasone 40 mg. Dose level 1: 40 mg in combination with Lipodox and Dexamethasone. Dose level 2: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone. Dose level 2m: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone. Dose level 3m: 80 mg (D1,3,8,10) in combination with Lipodox and Dexamethasone.
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
NUMBER
population Description
All participants treated during dose escalation
reporting Status
POSTED
time Frame
Up to 12 months
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice