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
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.
Number of participants with refractory or relapse Myeloma who still remain alive two years post transplant
Number of Participants who experienced grade 3 or higher Adverse Events during the first 100 days of the transplant.
Reported safety
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Triangle