A Phase 2 interventional study of Panobinostat in Multiple Myeloma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
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).
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 30 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule.
Drug: Panobinostat
Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule.
Drug: Panobinostat
Maintenance therapy dosing as outlined in Cohorts A and B.
Also known as: LBH589
Relative Dose Intensity (RDI) Per Cohort
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).
Time frame: Up to 2 years
Complete Response Rate
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.
Time frame: Up to 5 years
Progression Free Survival (PFS)
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 tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Time frame: at 2 years
Overall Survival (OS)
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.
Time frame: at 2 years
| Milestone | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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).
| percentage of dose | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Relative Dose Intensity (RDI) Per Cohort | 97.9 (77.1 to 100) | 89.6 (63.1 to 100) |
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.
| percentage | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Complete Response Rate | 73.33 (44.9 to 92.2) | 66.6 (38.4 to 88.2) |
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 tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
| percentage of participants | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Progression Free Survival (PFS) | 71.8 (41.1 to 88.4) | 53.3 (26.3 to 74.4) |
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.
| percentage of participants | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Overall Survival (OS) | 100 (NA to NA) | 100 (NA to NA) |
Collected over Adverse events collected from date of consent until off study date, 4 years, 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Maintenance Therapy | 0/15 (0%) | 2/15 (13.3%) | 10/15 (66.7%) |
| Cohort B: Maintenance Therapy | 0/15 (0%) | 3/15 (20%) | 11/15 (73.3%) |
| Event | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| Lung infectionInfections and infestations | 0/15 | 2/15 |
| Flu like symptomsGeneral disorders | 0/15 | 1/15 |
| ColitisGastrointestinal disorders | 1/15 | 0/15 |
| HeadacheNervous system disorders | 1/15 | 0/15 |
| FeverGeneral disorders | 0/15 | 1/15 |
| Bone painMusculoskeletal and connective tissue disorders | 1/15 | 0/15 |
| CholecystitisGastrointestinal disorders | 1/15 | 0/15 |
| Event | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy |
|---|---|---|
| White blood cell decreasedInvestigations | 6/15 | 3/15 |
| Cholesterol highInvestigations | 6/15 | 0/15 |
| HypertensionVascular disorders | 5/15 | 5/15 |
| HyperglycemiaMetabolism and nutrition disorders | 5/15 | 2/15 |
| AnemiaBlood and lymphatic system disorders | 5/15 | 5/15 |
| FatigueGeneral disorders | 5/15 | 2/15 |
| Platelet count decreasedInvestigations | 4/15 | 4/15 |
| Back PainMusculoskeletal and connective tissue disorders | 4/15 | 3/15 |
| Peripheral motor neuropathyNervous system disorders | 4/15 | 2/15 |
| Lymphocyte count decreasedInvestigations | 4/15 | 1/15 |
| Age, Categorical(Participants) | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 8 | 19 |
| >=65 years | 4 | 7 | 11 |
| Sex: Female, Male(Participants) | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 9 | 10 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 12 | 15 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 13 | 13 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort A: Maintenance Therapy | Cohort B: Maintenance Therapy | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
H. Lee Moffitt Cancer Center and Research Institute