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 CohortPrimary· 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).
Group
Value
95% CI
Cohort A: Maintenance Therapy
97.9
77.1 – 100
Cohort B: Maintenance Therapy
89.6
63.1 – 100
Complete Response RateSecondary· 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.
Group
Value
95% CI
Cohort A: Maintenance Therapy
73.33
44.9 – 92.2
Cohort B: Maintenance Therapy
66.6
38.4 – 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
Group
Value
95% CI
Cohort A: Maintenance Therapy
71.8
41.1 – 88.4
Cohort B: Maintenance Therapy
53.3
26.3 – 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.
Group
Value
95% CI
Cohort A: Maintenance Therapy
100
NA – NA
Cohort B: Maintenance Therapy
100
NA – 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)
Reaction
System
Cohort A: Maintenance Ther…
Cohort B: Maintenance Ther…
Lung infection
Infections and infestations
—
—
Flu like symptoms
General disorders
—
—
Colitis
Gastrointestinal disorders
—
—
Headache
Nervous system disorders
—
—
Fever
General disorders
—
—
Bone pain
Musculoskeletal and connective tissue disorders
—
—
Cholecystitis
Gastrointestinal disorders
—
—
Other adverse events (46 terms — click to expand)
Reaction
System
Cohort A: Maintenance Ther…
Cohort B: Maintenance Ther…
White blood cell decreased
Investigations
—
—
Cholesterol high
Investigations
—
—
Hypertension
Vascular disorders
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Fatigue
General disorders
—
—
Platelet count decreased
Investigations
—
—
Back Pain
Musculoskeletal and connective tissue disorders
—
—
Peripheral motor neuropathy
Nervous system disorders
—
—
Lymphocyte count decreased
Investigations
—
—
Upper respiratory infection
Infections and infestations
—
—
Neutrophil count decreased
Investigations
—
—
Hypophosphatemia
Metabolism and nutrition disorders
—
—
Bone pain
Musculoskeletal and connective tissue disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Gastroesophageal reflux disease
Gastrointestinal disorders
—
—
Arthritis
Musculoskeletal and connective tissue disorders
—
—
Insomnia
Psychiatric disorders
—
—
Hypertriglyceridemia
Metabolism and nutrition disorders
—
—
Headache
Nervous system disorders
—
—
Thrombocytopenia
Investigations
—
—
Neck pain
Musculoskeletal and connective tissue disorders
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
Hypercalcemia
Metabolism and nutrition disorders
—
—
Creatinine increased
Investigations
—
—
Chronic kidney disease
Renal and urinary disorders
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
Hypocalcemia
Metabolism and nutrition disorders
—
—
Hyperkalemia
Metabolism and nutrition disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Productive cough
Respiratory, thoracic and mediastinal disorders
—
—
Fracture
Musculoskeletal and connective tissue disorders
—
—
Polyuria and nocturia
Renal and urinary disorders
—
—
INR increased
Investigations
—
—
Musculoskeletal and connective tissue disorders -Other
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):
NCT05725200 — Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
· Phase 2
· recruiting
NCT04341311 — Phase I Study of Marizomib + Panobinostat for Children With DIPG
· Phase 1
· terminated
NCT03878524 — Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
· Phase 1
· terminated
NCT04897880 — A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT
· Phase 2
· terminated
NCT04326764 — Panobinostat Maintenance After HSCT fo High-risk AML and MDS
· Phase 3
· terminated
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· 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
· Phase 3
· recruiting
Other H. Lee Moffitt Cancer Center and Research Institute trials
Trials by the same sponsor.
NCT05041335 — Wet Heparinized Suction for Abdominal Cancer
· NA
· not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
· NA
· recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
· Phase 1
· recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
· Phase 2
· recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
· Phase 1
· recruiting
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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 1 November 2022
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.