Trial · NCT02506959
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
NCT02506959, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma. Trials, record NCT02506959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02506959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
- NCT number
- NCT02506959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Plasma Cell Leukemia, Plasmacytoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Autologous Hematopoietic Stem Cell Transplantation, Busulfan, Gemcitabine Hydrochloride, Melphalan, Panobinostat, Peripheral Blood Stem Cell Transplantation, Pharmacological Study
- First posted
- 2015-07-23
- Last updated
- 2025-03-18
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 1 year | 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. |
| Secondary | Overall Survival (OS) | Up to 2 years | Number of participants with refractory or relapse Myeloma who still remain alive two years post transplant |
| Secondary | Participants Who Experienced Grade 3 or Higher Adverse Events | Up to day 100 | Number of Participants who experienced grade 3 or higher Adverse Events during the first 100 days of the transplant. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Participants Who Experienced Grade 3 or Higher Adverse Events | Up to day 100 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 38 | Participants | ||
| Progression Free Survival (PFS) | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 24 | Participants | ||
| Overall Survival (OS) | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 27 | Participants | ||
| Overall Survival (OS) | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 16 | Participants | ||
| Participants Who Experienced Grade 3 or Higher Adverse Events | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 47 | Participants | ||
| Participants Who Experienced Grade 3 or Higher Adverse Events | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 29 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 50 | |
| Overall Study | STARTED | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 33 | |
| Overall Study | COMPLETED | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 48 | |
| Overall Study | COMPLETED | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 32 | |
| Overall Study | NOT COMPLETED | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 2 | |
| Overall Study | NOT COMPLETED | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 1 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 1 | 50 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 2 | 33 | 2 |
| other | ALK increased | Investigations | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 2 | 50 | 2 |
| other | ALK increased | Investigations | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 3 | 33 | 3 |
| other | Allergic reaction | Immune system disorders | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 1 | 50 | 1 |
| other | Allergic reaction | Immune system disorders | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 1 | 33 | 1 |
| other | ALT increased | Investigations | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 25 | 50 | 25 |
| other | ALT increased | Investigations | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 20 | 33 | 20 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 0 | 50 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 1 | 33 | 1 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 23 | 50 |
| Total, all-cause mortality | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 17 | 33 |
| Total, other adverse events | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 47 | 50 |
| Total, other adverse events | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 30 | 33 |
| Total, serious adverse events | Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 2 | 50 |
| Total, serious adverse events | Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel | 4 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel vs Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel: Participants Who Experienced Grade 3 or Higher Adverse Events | Trial comparisons |
| Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel vs Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel: Overall Survival (OS) | Trial comparisons |
| Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel vs Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel: Progression Free Survival (PFS) | Trial comparisons |
| Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel vs Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel: deaths from any cause | Trial comparisons |
| Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel vs Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02506959
GET https://conductscience.org/api/trials/v1/NCT02506959/events?page=2