Trial · NCT02654990
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
NCT02654990, Phase 2, Completed, pharmaand GmbH; results first posted 2024-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma. Trials, record NCT02654990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
- NCT number
- NCT02654990
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 248 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Multiple Myeloma
- Interventions
- Panobinostat Capsules, Bortezomib Injection, Dexamethasone tablets
- First posted
- 2016-01-13
- Last updated
- 2024-07-12
- Other registries' IDs
- eudract:2015-001564-19
- Results first posted
- 2024-07-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 168 days | ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria. |
| Secondary | ORR Throughout the Study | Up to 5.2 years | ORR is defined as the percentage of participants with a confirmed PR or better (iCR or sCR or CR or VGPR) as their best overall response throughout the entire study. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until PD, death, start of new therapy, withdrawal of consent or end of study, whatever came first. ORR was assessed blindly per IRC according to IMWG criteria. |
| Secondary | iCR Rate | Up to 5.2 years | iCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry; absence of phenotypically aberrant plasma cells (clonal) in bone marrow (BM) with a minimum of 1 million total BM cells analyzed by multiparametric flow cytometry (\>4 colors). Results reported as percentage of participants achieving iCR. |
| Secondary | sCR Rate | Up to 5.2 years | sCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal FLC ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry. Results reported as percentage of participants achieving sCR. |
| Secondary | CR Rate | Up to 5.2 years | CR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; in case the only measurable disease at baseline is the serum FLC assessment, a normal FLC ratio of 0.26 to 1.65 is required additionally to qualify for CR. Results reported as percentage of participants achieving CR. |
| Secondary | VGPR Rate | Up to 5.2 years | VGPR, based on IMWG criteria per blinded IRC assessment, is defined as: serum and/or urine M protein detectable by immunofixation but not on protein electrophoresis, or ≥90% reduction from baseline in serum) and urine M protein \<100 milligrams/24 hours); in the case of the presence of any soft tissue plasmacytoma(s) at baseline, a reduction in the sum of the products of the cross-diameters by ≥50% from baseline is required; in case the only measurable disease in a participant at baseline is the serum FLC level (that is, no measurable disease in serum and urine PEP), a decrease of \>90% in the difference between involved and uninvolved FLC levels from baseline is required. Results reported as percentage of participants achieving VGPR. |
| Secondary | Progression-free Survival (PFS) | Up to 5.2 years | PFS, assessed based on IMWG criteria per blind IRC assessment, is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death). |
| Secondary | Overall Survival (OS) | Up to 5.2 years | OS is defined as the time from date of randomization to the date of death due to any cause. |
| Secondary | Maximum Plasma Concentration (Cmax): Panobinostat | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Serial blood samples were collected for panobinostat Cmax analysis. Results are reported in nanograms/milliliter (ng/mL). |
| Secondary | Cmax: Bortezomib | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 168 days | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | ORR Throughout the Study | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | iCR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | sCR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | CR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | VGPR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Maximum Plasma Concentration (Cmax): Panobinostat | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | ng/mL | MEAN |
| SECONDARY | Cmax: Bortezomib | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | ng/mL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Arm A - Panobinostat (20 mg, TIW) | 62.2 | 95% Confidence Interval 50.8 to 72.7 | percentage of participants | |
| Overall Response Rate (ORR) | Arm B - Panobinostat (20 mg, BIW) | 65.1 | 95% Confidence Interval 53.8 to 75.2 | percentage of participants | |
| Overall Response Rate (ORR) | Arm C - Panobinostat (10 mg, TIW) | 50.6 | 95% Confidence Interval 39.4 to 61.8 | percentage of participants | |
| ORR Throughout the Study | Arm A - Panobinostat (20 mg, TIW) | 62.2 | 95% Confidence Interval 50.8 to 72.7 | percentage of participants | |
| ORR Throughout the Study | Arm B - Panobinostat (20 mg, BIW) | 67.5 | 95% Confidence Interval 56.3 to 77.4 | percentage of participants | |
| ORR Throughout the Study | Arm C - Panobinostat (10 mg, TIW) | 53.0 | 95% Confidence Interval 41.7 to 64.1 | percentage of participants | |
| iCR Rate | Arm A - Panobinostat (20 mg, TIW) | 3.7 | percentage of participants | ||
| iCR Rate | Arm B - Panobinostat (20 mg, BIW) | 1.2 | percentage of participants | ||
| iCR Rate | Arm C - Panobinostat (10 mg, TIW) | 1.2 | percentage of participants | ||
| sCR Rate | Arm A - Panobinostat (20 mg, TIW) | 1.2 | percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Panobinostat (20 mg, TIW) | 82 | |
| Overall Study | STARTED | Arm B - Panobinostat (20 mg, BIW) | 83 | |
| Overall Study | STARTED | Arm C - Panobinostat (10 mg, TIW) | 83 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A - Panobinostat (20 mg, TIW) | 79 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm B - Panobinostat (20 mg, BIW) | 82 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm C - Panobinostat (10 mg, TIW) | 80 | |
| Overall Study | COMPLETED | Arm A - Panobinostat (20 mg, TIW) | 82 | |
| Overall Study | COMPLETED | Arm B - Panobinostat (20 mg, BIW) | 83 | |
| Overall Study | COMPLETED | Arm C - Panobinostat (10 mg, TIW) | 83 | |
| Overall Study | NOT COMPLETED | Arm A - Panobinostat (20 mg, TIW) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events570
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 | Thrombocytopenia | Blood and lymphatic system disorders | Arm A - Panobinostat (20 mg, TIW) | 43 | 78 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B - Panobinostat (20 mg, BIW) | 37 | 83 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm C - Panobinostat (10 mg, TIW) | 26 | 80 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A - Panobinostat (20 mg, TIW) | 33 | 78 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B - Panobinostat (20 mg, BIW) | 22 | 83 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm C - Panobinostat (10 mg, TIW) | 24 | 80 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A - Panobinostat (20 mg, TIW) | 25 | 78 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B - Panobinostat (20 mg, BIW) | 16 | 83 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm C - Panobinostat (10 mg, TIW) | 10 | 80 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A - Panobinostat (20 mg, TIW) | 5 | 78 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Panobinostat (20 mg, TIW) | 34 | 78 |
| Total, all-cause mortality | Arm B - Panobinostat (20 mg, BIW) | 41 | 83 |
| Total, all-cause mortality | Arm C - Panobinostat (10 mg, TIW) | 47 | 80 |
| Total, other adverse events | Arm A - Panobinostat (20 mg, TIW) | 78 | 78 |
| Total, other adverse events | Arm B - Panobinostat (20 mg, BIW) | 82 | 83 |
| Total, other adverse events | Arm C - Panobinostat (10 mg, TIW) | 78 | 80 |
| Total, serious adverse events | Arm A - Panobinostat (20 mg, TIW) | 44 | 78 |
| Total, serious adverse events | Arm B - Panobinostat (20 mg, BIW) | 40 | 83 |
| Total, serious adverse events | Arm C - Panobinostat (10 mg, TIW) | 36 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33301738 | 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/NCT02654990
GET https://conductscience.org/api/trials/v1/NCT02654990/results?page=2