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NCT02780609 · OUTCOME

Rate of Minimal Residual Disease (MRD)

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
percentage of participants
Interval / dispersion
Not reported
Time frame
3 months post HCT

What was measured

Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.

Analysis population: Evaluable participants

Groups in this outcome

Phase 1 Level 1: Selinexor Plus HDM HCT

40 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.

Phase 1 Level 2: Selinexor Plus HDM HCT

60 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).

Phase 1 Level 3: 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).

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 Level 1: Selinexor Plus HDM HCT3
Phase 1 Level 2: Selinexor Plus HDM HCT2
Phase 1 Level 3: Selinexor Plus HDM HCT6
Phase 2: Selinexor Plus HDM HCT9

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Level 1: Selinexor Plus HDM HCT33.3Not reportedNot reportedNot reportedNot reported
Phase 1 Level 2: Selinexor Plus HDM HCT100Not reportedNot reportedNot reportedNot reported
Phase 1 Level 3: Selinexor Plus HDM HCT16.7Not reportedNot reportedNot reportedNot reported
Phase 2: Selinexor Plus HDM HCT33.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        16.7
      4. group Id
        OG003
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      9
    units
    Participants
description
Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.
groups
  1. description
    40 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 Level 1: Selinexor Plus HDM HCT
  2. description
    60 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).
    id
    OG001
    title
    Phase 1 Level 2: Selinexor Plus HDM HCT
  3. 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).
    id
    OG002
    title
    Phase 1 Level 3: Selinexor Plus HDM HCT
  4. 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
    OG003
    title
    Phase 2: Selinexor Plus HDM HCT
param Type
NUMBER
population Description
Evaluable participants
reporting Status
POSTED
time Frame
3 months post HCT
title
Rate of Minimal Residual Disease (MRD)
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice