Trial · NCT02290431
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
NCT02290431, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma. Trials, record NCT02290431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290431
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT02290431
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapse/Refractory Multiple Myeloma
- Interventions
- LBH589 (panobinostat), bortezomib, dexamethasone
- First posted
- 2014-11-14
- Last updated
- 2019-11-18
- Results first posted
- 2019-11-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | after 24 weeks (8 cycles; cycle = 21 days) | nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response. |
| Secondary | Progression Free Survival (PFS) | duration of study up to approx. 4 years | PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment |
| Secondary | Overall Response Rate (ORR) | 24 weeks (8 cycles; cycle = 21 days) | ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment |
| Secondary | Overall Survival (OS) | up to 30 days after end of study, approx. 4 years | OS is defined as time from first dose of study treatment to death |
| Secondary | Minimal Response Rate (MRR) Per Investigator | after 24 weeks (8 cycles; cycle = 21 days) | MRR is based on modified EBMT criteria per investigator assessment |
| Secondary | Time to Response (TTR) Per Investigator | duration of study up to approx. 4 years | TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator |
| Secondary | Time to Progression/Relapse (TTP) Per Investigator | duration of study up to approx. 4 years | TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse |
| Secondary | Duration of Response (DOR) Per Investigator | duration of study up to approx. 4 years | DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM |
| Secondary | Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156 | QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL. |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | after 24 weeks (8 cycles; cycle = 21 days) | Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | 24 weeks (8 cycles; cycle = 21 days) | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | up to 30 days after end of study, approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Minimal Response Rate (MRR) Per Investigator | after 24 weeks (8 cycles; cycle = 21 days) | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Time to Progression/Relapse (TTP) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156 | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | scores on a scale | MEDIAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | h.ng/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | LBH589 + Bortezomib + Dexamethasone | 48.4 | 90% Confidence Interval 33.6 to 63.2 | Percentage of participants | |
| Progression Free Survival (PFS) | LBH589 + Bortezomib + Dexamethasone | 15.3 | 95% Confidence Interval 10.4 to 31.4 | months | |
| Overall Response Rate (ORR) | LBH589 + Bortezomib + Dexamethasone | 80.6 | 95% Confidence Interval 62.5 to 92.5 | Percentage of participants | |
| Overall Survival (OS) | LBH589 + Bortezomib + Dexamethasone | NA | 95% Confidence Interval NA to NA | months | |
| Minimal Response Rate (MRR) Per Investigator | LBH589 + Bortezomib + Dexamethasone | 9.7 | Percentage of participants | ||
| Time to Response (TTR) Per Investigator | LBH589 + Bortezomib + Dexamethasone | 1.4 | 95% Confidence Interval 0.7 to 2.1 | months | |
| Time to Progression/Relapse (TTP) Per Investigator | LBH589 + Bortezomib + Dexamethasone | 15.3 | 95% Confidence Interval 10.4 to 31.4 | months | |
| Duration of Response (DOR) Per Investigator | LBH589 + Bortezomib + Dexamethasone | 22.7 | 95% Confidence Interval 9.7 to 30.5 | months | |
| Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | LBH589 + Bortezomib + Dexamethasone | Baseline | 112.33 | Full Range 80.7 to 144.5 | scores on a scale |
| Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | LBH589 + Bortezomib + Dexamethasone | Week 12 | 91.75 | Full Range 65.7 to 147.0 | scores on a scale |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LBH589 + Bortezomib + Dexamethasone | 31 | |
| Overall Study | Subjects. Discont. Prematurely | LBH589 + Bortezomib + Dexamethasone | 27 | |
| Overall Study | Subjects Completed Study Per Protocol | LBH589 + Bortezomib + Dexamethasone | 8 | |
| Overall Study | Subjs. Ntered Post-treatment Eval. Phase | LBH589 + Bortezomib + Dexamethasone | 31 | |
| Overall Study | Subjects Entered Survival f/u Phase | LBH589 + Bortezomib + Dexamethasone | 24 | |
| Overall Study | Entered Treatment Phase 2 | LBH589 + Bortezomib + Dexamethasone | 17 | |
| Overall Study | COMPLETED | LBH589 + Bortezomib + Dexamethasone | 4 | |
| Overall Study | NOT COMPLETED | LBH589 + Bortezomib + Dexamethasone | 27 |
Source ClinicalTrials.gov
Adverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LBH589 + Bortezomib + Dexamethasone | 10 | 31 | |
| other | Leukopenia | Blood and lymphatic system disorders | LBH589 + Bortezomib + Dexamethasone | 4 | 31 | |
| other | Lymphopenia | Blood and lymphatic system disorders | LBH589 + Bortezomib + Dexamethasone | 5 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | LBH589 + Bortezomib + Dexamethasone | 7 | 31 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LBH589 + Bortezomib + Dexamethasone | 17 | 31 | |
| other | Cataract | Eye disorders | LBH589 + Bortezomib + Dexamethasone | 3 | 31 | |
| other | Constipation | Gastrointestinal disorders | LBH589 + Bortezomib + Dexamethasone | 13 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | LBH589 + Bortezomib + Dexamethasone | 25 | 31 | |
| other | Dyspepsia | Gastrointestinal disorders | LBH589 + Bortezomib + Dexamethasone | 2 | 31 | |
| other | Gastritis | Gastrointestinal disorders | LBH589 + Bortezomib + Dexamethasone | 3 | 31 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LBH589 + Bortezomib + Dexamethasone | 0 | 31 |
| Total, other adverse events | LBH589 + Bortezomib + Dexamethasone | 31 | 31 |
| Total, serious adverse events | LBH589 + Bortezomib + Dexamethasone | 14 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33279887 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02290431
GET https://conductscience.org/api/trials/v1/NCT02290431/results?page=2