Trial · NCT03256045
Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
NCT03256045, Phase 2, Terminated, University of Washington; results first posted 2022-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. Trials, record NCT03256045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03256045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT03256045
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Carfilzomib, Chemosensitivity Assay, Dexamethasone, Laboratory Biomarker Analysis, Panobinostat
- First posted
- 2017-08-21
- Last updated
- 2022-05-09
- Results first posted
- 2022-05-09
- Limitations and caveats
Study was limited by lower accrual than expected due to: competing studies, other investigators' treatment preferences, and ultimately, the departure of the initial PI from the institution. Because of PI's departure and lab closure, the study closed to accrual after the 9th patient enrolled. Because only 9 subjects were enrolled and some in-vitro assay results are unavailable, it is difficult to analyze the in-vitro assay results and determine the parameters that predict disease response.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response, by Subject | 14 months | Assessed using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. Key: 1 = very good partial response (VGPR); 2 = partial response (PR); 3 = minimal response (MR); 4 = stable disease (SD); 5 = progressive disease (PD). Please see IC50 and CI results in the other primary outcome measures. |
| Primary | Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject | At baseline | Multiple myeloma cells are added to assay with panobinostat. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-9. |
| Primary | Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject | At baseline | Multiple myeloma cells are added to assay with carfilzomib. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. |
| Primary | Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject | At baseline | Multiple myeloma cells are added to assay with dexamethasone. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-6. |
| Primary | Synergy of Panobinostat and Carfilzomib in Combination, Per Subject. | At baseline | Concentration of carfilzomib and panobinostat in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism. |
| Primary | Synergy of Panobinostat and Dexamethasone in Combination, Per Subject | At baseline | Concentration of panobinostat and dexamethasone in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response, by Subject | 14 months | IMWG Uniform Response Grade | NUMBER | |
| PRIMARY | Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject | At baseline | nM | NUMBER | |
| PRIMARY | Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject | At baseline | nM | NUMBER | |
| PRIMARY | Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject | At baseline | Results for subject MM-92 were not reported. | uM | NUMBER |
| PRIMARY | Synergy of Panobinostat and Carfilzomib in Combination, Per Subject. | At baseline | CI score was not reported for subject MM-82. | Combination index | NUMBER |
| PRIMARY | Synergy of Panobinostat and Dexamethasone in Combination, Per Subject | At baseline | CI score was not reported for subject MM-82 | CI score | NUMBER |
Source ClinicalTrials.gov
Results by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-82 | 4 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-91 | 2 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-92 | 2 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-95 | 1 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-96 | 1 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-98 | 1 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-99 | 3 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-109 | 4 | IMWG Uniform Response Grade | |
| Best Overall Response, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject M-111 | 1 | IMWG Uniform Response Grade | |
| Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | Subject MM-82 | 3.8 | nM |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 9 | |
| Overall Study | COMPLETED | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 9 | |
| Overall Study | NOT COMPLETED | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 0 |
Source ClinicalTrials.gov
Adverse events7
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 | Hypertension | Vascular disorders | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 2 | 9 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
| other | Syncope | Nervous system disorders | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
| serious | Non-ST segment elevation myocardial infarction | Cardiac disorders | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
| serious | Fracture, pathologic | Injury, poisoning and procedural complications | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
| serious | Fracture, non-pathologic | Injury, poisoning and procedural complications | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
| serious | Fall | Injury, poisoning and procedural complications | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 0 | 9 |
| Total, other adverse events | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 4 | 9 |
| Total, serious adverse events | Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 3 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT03256045
GET https://conductscience.org/api/trials/v1/NCT03256045/results?page=2