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Comparison · NCT02506959-083b6277

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

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT02506959-083b6277. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02506959-083b6277

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.940.8380.979wilson
Risk in group 20.8790.7270.952wilson
Risk difference, group 1 minus group 20.0612-0.06440.218newcombe hybrid score
Risk ratio, group 1 over group 21.070.9251.24log
Odds ratio, group 1 over group 22.160.45110.4log
Number needed to treat, for one more participant with the outcome on Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel than on Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
16.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cohort 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
4750OG000
Group 2Cohort 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
2933OG001

Outcome

Type
SECONDARY
Title
Participants Who Experienced Grade 3 or Higher Adverse Events
Description
Number of Participants who experienced grade 3 or higher Adverse Events during the first 100 days of the transplant.
Time frame
Up to day 100
Population

Source ClinicalTrials.gov

Trial

Title
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
NCT number
NCT02506959
Phases
PHASE2
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
Lead sponsor
M.D. Anderson Cancer Center
Results first posted
2025-03-18

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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