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NCT02506959 · STUDY IN CONTEXT

Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT02506959
trial label
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0000
    source section id
    NCT02506959-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    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.
    time origin
    1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0001
    source section id
    NCT02506959-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Number of participants with refractory or relapse Myeloma who still remain alive two years post transplant
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0002
    source section id
    NCT02506959-om-0002
    source outcome index
    2
    endpoint
    Participants Who Experienced Grade 3 or Higher Adverse Events
    endpoint definition
    Number of Participants who experienced grade 3 or higher Adverse Events during the first 100 days of the transplant.
    time origin
    Up to day 100
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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 Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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 Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    regimen
    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
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02506959-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    harm key
    EG000
    source section id
    NCT02506959-ae
    event group key
    EG000
    event group label
    Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    serious affected
    2
    serious at risk
    50
    other affected
    47
    other at risk
    50
    frequency threshold
    0
    collection period
    Up to 2 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms-refractory-0d6d63cc
    nct id
    NCT02506959
    harm key
    EG001
    source section id
    NCT02506959-ae
    event group key
    EG001
    event group label
    Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
    serious affected
    4
    serious at risk
    33
    other affected
    30
    other at risk
    33
    frequency threshold
    0
    collection period
    Up to 2 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice