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.
Safety and TolerabilitySecondary· From Start of the Study up to 57 Weeks approximately.
Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazard
Participants with Adverse Events
Group
Value
95% CI
Panobinostat
38
Deaths
Group
Value
95% CI
Panobinostat
7
On treatment deaths
Group
Value
95% CI
Panobinostat
3
Serious Adverse Events
Group
Value
95% CI
Panobinostat
17
Study-drug-related Serious Adverse Events
Group
Value
95% CI
Panobinostat
3
Adverse Events Leading to discontinuation
Group
Value
95% CI
Panobinostat
8
Time to Peak Concentration (Tmax) of PanobinostatSecondary· Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Day 1
Group
Value
95% CI
Panobinostat
1.7
0.2 – 5.2
Day 8
Group
Value
95% CI
Panobinostat
1.2
0.2 – 23.7
Maximum Plasma Concentration (Cmax) of PanobinostatSecondary· Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Day 1
Group
Value
95% CI
Panobinostat
7.6
± 5.52
Day 8
Group
Value
95% CI
Panobinostat
9.7
± 6.51
Area Under the Plasma Concentration (AUC0-24) of PanobinostatSecondary· Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.
Day 1
Group
Value
95% CI
Panobinostat
72.0
± 36.10
Day 8
Group
Value
95% CI
Panobinostat
81.6
± 37.56
Last Observed Plasma Concentration (Clast) of PanobinostatSecondary· Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Day 1
Group
Value
95% CI
Panobinostat
0.3
± 0.18
Day 8
Group
Value
95% CI
Panobinostat
1.1
± 1.13
Time of Clast (Tlast) of PanobinostatSecondary· Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Day 1
Group
Value
95% CI
Panobinostat
47.8
24 – 50.2
Day 8
Group
Value
95% CI
Panobinostat
24.3
3.3 – 28.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From Start of the Study up to 57 Weeks approximately..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02717455 — Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma
· Phase 1
· completed
NCT00532675 — Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Mye
· Phase 1
· completed
NCT00449761 — Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
· Phase 2
· terminated
NCT00451035 — Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase
· Phase 2
· terminated
NCT00621244 — A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
· Phase 1, PHASE2
· completed
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
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· recruiting
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· recruiting
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· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 14 July 2021
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/NCT00445068.