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NCT02780609 · OUTCOME

Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)

Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma · Source last updated 2022-11-04

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

Measure
NUMBER
Unit
percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
at 24 months

What was measured

Progression Free Survival defined as the time from start of treatment to the time of progression or death.

Analysis population: All evaluable participants treated at dose level 3/RP2D.

Groups in this outcome

Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT

80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

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 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT15

Reported measurements

Source class 1
Values in percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT66.7Not reported35.885.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.8
        upper Limit
        85.4
        value
        66.7
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Progression Free Survival defined as the time from start of treatment to the time of progression or death.
dispersion Type
95% Confidence Interval
groups
  1. description
    80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
    id
    OG000
    title
    Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT
param Type
NUMBER
population Description
All evaluable participants treated at dose level 3/RP2D.
reporting Status
POSTED
time Frame
at 24 months
title
Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)
type
OTHER_PRE_SPECIFIED
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice