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NCT02722941

Panobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT)

Completed Phase 2 Results posted Last updated 1 November 2022
What this trial tests

Phase 2 trial testing Panobinostat in Multiple Myeloma in 30 participants. Completed in 18 January 2021.

Timeline
10 June 2016
Primary endpoint
7 June 2020
18 January 2021

Quick facts

Lead sponsorH. Lee Moffitt Cancer Center and Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment30
Start date10 June 2016
Primary completion7 June 2020
Estimated completion18 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Relative Dose Intensity (RDI) Per Cohort Primary · Up to 2 years

Investigators will calculate RDI for each cohort. Relative dose intensity (RDI) represents the ratio of the amount of a drug actually delivered \[actual dose intensity (DI)\] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of a chemotherapy treatment was actually achieved which may suggest the feasibility of planned treatment regimen. There are multitude of reports demonstrating a correlation between RDI and survival in cancer treatment. RDI = (total dose received by the patient = mg)/(planned full dose of drug = mg).

GroupValue95% CI
Cohort A: Maintenance Therapy97.977.1 – 100
Cohort B: Maintenance Therapy89.663.1 – 100
Complete Response Rate Secondary · Up to 5 years

Complete Response (CR) rate to panobinostat maintenance therapy after autologous HCT. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow.

GroupValue95% CI
Cohort A: Maintenance Therapy73.3344.9 – 92.2
Cohort B: Maintenance Therapy66.638.4 – 88.2
Progression Free Survival (PFS) Secondary · at 2 years

Progressive Disease (PD) according to Uniform Response Reporting Criteria for Multiple Myeloma by the International Myeloma Working Group (IMWG). Increase of 25% from lowest response value in any of the following: * Serum M- component (absolute increase must be ≥ 0.5 g/dL) * Urine M-component (absolute increase must be ≥ 200 mg/24 h) * Only in patients without measurable serum and urine M protein levels and without measurable disease by free light chain (FLC) levels, bone marrow plasma cell percentage (absolute percentage must be ≥ 10% ) * Definite development of new bone lesions or soft tiss

GroupValue95% CI
Cohort A: Maintenance Therapy71.841.1 – 88.4
Cohort B: Maintenance Therapy53.326.3 – 74.4
Overall Survival (OS) Secondary · at 2 years

OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

GroupValue95% CI
Cohort A: Maintenance Therapy100NA – NA
Cohort B: Maintenance Therapy100NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected from date of consent until off study date, 4 years, 2 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A: Maintenance Therapy
Serious: 2/15 (13%)
Deaths: 0/15
Cohort B: Maintenance Therapy
Serious: 3/15 (20%)
Deaths: 0/15

Serious adverse events (7 terms)

ReactionSystemCohort A: Maintenance Ther…Cohort B: Maintenance Ther…
Lung infectionInfections and infestations
Flu like symptomsGeneral disorders
ColitisGastrointestinal disorders
HeadacheNervous system disorders
FeverGeneral disorders
Bone painMusculoskeletal and connective tissue disorders
CholecystitisGastrointestinal disorders
Other adverse events (46 terms — click to expand)

ReactionSystemCohort A: Maintenance Ther…Cohort B: Maintenance Ther…
White blood cell decreasedInvestigations
Cholesterol highInvestigations
HypertensionVascular disorders
HyperglycemiaMetabolism and nutrition disorders
AnemiaBlood and lymphatic system disorders
FatigueGeneral disorders
Platelet count decreasedInvestigations
Back PainMusculoskeletal and connective tissue disorders
Peripheral motor neuropathyNervous system disorders
Lymphocyte count decreasedInvestigations
Upper respiratory infectionInfections and infestations
Neutrophil count decreasedInvestigations
HypophosphatemiaMetabolism and nutrition disorders
Bone painMusculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
ArthritisMusculoskeletal and connective tissue disorders
InsomniaPsychiatric disorders
HypertriglyceridemiaMetabolism and nutrition disorders
HeadacheNervous system disorders
ThrombocytopeniaInvestigations
Neck painMusculoskeletal and connective tissue disorders
Peripheral sensory neuropathyNervous system disorders
HypercalcemiaMetabolism and nutrition disorders
Creatinine increasedInvestigations
Chronic kidney diseaseRenal and urinary disorders
HypokalemiaMetabolism and nutrition disorders
HypocalcemiaMetabolism and nutrition disorders
HyperkalemiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
Productive coughRespiratory, thoracic and mediastinal disorders
FractureMusculoskeletal and connective tissue disorders
Polyuria and nocturiaRenal and urinary disorders
INR increasedInvestigations
Musculoskeletal and connective tissue disorders -OtherMusculoskeletal and connective tissue disorders
CholecystitisHepatobiliary disorders
CholecystectomyGastrointestinal disorders
Atrial fibrilationCardiac disorders
ArthalgiaMusculoskeletal and connective tissue disorders
FibromyalgiaNervous system disorders

Most-reported serious reactions: Lung infection, Flu like symptoms, Colitis, Headache, Fever, Bone pain, Cholecystitis.

Data from ClinicalTrials.gov NCT02722941 adverse events section.

Sponsor's own description

The purpose of this study is to learn more about ways to prevent or delay relapse of multiple myeloma (MM). This study will determine the best dosing schedule of LBH589 maintenance therapy as well as the safety (side effects) and tolerability of LBH589 maintenance therapy after autologous hematopoietic cell transplant (HCT).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
    Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
  2. New Insights Into the Role of Phenotypic Plasticity and EMT in Driving Cancer Progression.
    Bhatia S, Wang P, Toh A, Thompson EW. · · 2020 · cited 63× · PMID 32391381 · DOI 10.3389/fmolb.2020.00071
  3. Efficacy of Panobinostat for the Treatment of Multiple Myeloma.
    Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Gavriatopoulou M, et al · · 2020 · cited 56× · PMID 32411240 · DOI 10.1155/2020/7131802
  4. Posttransplant maintenance therapy in multiple myeloma: the changing landscape.
    Sengsayadeth S, Malard F, Savani BN, Garderet L, et al · · 2017 · cited 25× · PMID 28338672 · DOI 10.1038/bcj.2017.23
  5. Investigating the Interplay between Myeloma Cells and Bone Marrow Stromal Cells in the Development of Drug Resistance: Dissecting the Role of Epigenetic Modifications.
    Schütt J, Nägler T, Schenk T, Brioli A. · · 2021 · cited 8× · PMID 34439223 · DOI 10.3390/cancers13164069

Verify or expand the search:

Other trials of Panobinostat

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02722941.

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