Trial · NCT04956302
Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT04956302, Phase 1, Terminated, Abdullah Khan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma. Trials, record NCT04956302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04956302
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT04956302
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Abdullah Khan
- Conditions
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone, Panobinostat Lactate
- First posted
- 2021-07-09
- Last updated
- 2024-06-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose | End of cycle 1 (1 cycle = 28 days) | A standard "3+3" design will be used to determine the safe and tolerable dose level. |
| Primary | Incidence of adverse events | Up to 3 years | Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. |
| Secondary | Time to progression | From start of treatment until objective tumor progression, assessed up to 3 years | Cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks. |
| Secondary | Progression-free survival | From start of treatment until disease progression or death, assessed at 1 year | Will be calculated using the Kaplan-Meier method. Will be calculated together with 95% confidence intervals, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Objective response rate (ORR) | Up to 3 years | ORR will be defined as the total number of subjects whose best response is partial response (PR) or better divided by the number of patients. ORR will be reported overall as well as by dose level, with 95% binomial exact confidence intervals. Comparison of ORR among patient subgroups will be conducted using Fisher exact test. |
| Secondary | Time to response | From start of treatment until measurement criteria are first met for PR, very good partial response, or complete response, assessed up to 3 years | Cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks. |
| Secondary | Duration of overall response | From the time measurement criteria are first met for partial response or better (whichever status is recorded first) until the first date of progressive disease or death, assessed up to 3 years | Will be calculated using the Kaplan-Meier method. Will be calculated together with 95% confidence intervals, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Overall survival | From start of treatment to the date of his or her death, assessed at 1 year | Will be calculated using the Kaplan-Meier method. Will be calculated together with 95% confidence intervals, and log-rank test will be used for the comparison between patient subgroups. |
| Other | Plasma cell expression of CD38 | Baseline up to 60 days | Will be explored graphically (e.g. side-by-side boxplots) and with quantitative summaries, compared using Mann-Whitney test or Fisher exact test depending on the data type of expression data. |
| Other | Changes in lymphocyte subsets with therapy | Baseline up to 60 days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04956302
GET https://conductscience.org/api/trials/v1/NCT04956302/registered