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NCT02506959 · OUTCOME

Progression Free Survival (PFS)

Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma · Source last updated 2025-03-18

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
1 year

What was measured

Number of participants alive and disease free one year post auto transplant in patients with refractory or relapsed myeloma receiving panobinostat/gemcitabine/busulfan/melphalan (panobinostat/Gem/Bu/Mel) with autologous stem-cell transplant, either as a first or a salvage stem-cell transplant.

Groups in this outcome

Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel

Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies

Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel

Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel50
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel33

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel38Not reportedNot reportedNot reportedNot reported
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        24
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      33
    units
    Participants
description
Number of participants alive and disease free one year post auto transplant in patients with refractory or relapsed myeloma receiving panobinostat/gemcitabine/busulfan/melphalan (panobinostat/Gem/Bu/Mel) with autologous stem-cell transplant, either as a first or a salvage stem-cell transplant.
groups
  1. description
    Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
    id
    OG000
    title
    Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
  2. description
    Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
    id
    OG001
    title
    Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
1 year
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice