Trial · NCT02756663
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) using investigator's response assessment | All patients treated for 6 cycles (cycle=28 days) | The primary endpoint if Overall Response Rate (ORR) using investigator response assessment according to IMWG criteria. The analysis of ORR will be performed after all randomized patients have completed 6 months of study treatment or discontinued treatment earlier. |
| Secondary | Very Good Partial Response (VGPR) or better as best response using investigator response assessment based on International Myeloma Working Group (IMWG) criteria | All patients treated for 6 cycles (cycle=28 days) | Investigators' response assessment assessed on IMWG criteria will be used. The VGPR or better rate is defined as the proportion of patients with a confirmed VGPR or better response as their best overall response. |
| Secondary | Progression-free survival (PFS) using investigator's response assessment based on IMWG criteria | All patients treated for 6 cycles (cycle=28 days) | PFS 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) | All patients treated for 6 cycles (cycle=28 days) | OS is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. |
| Secondary | Time to response (TTR) using investigator's response assessment based on IMWG criteria | All patients treated for 6 cycles (cycle=28 days) | TTR is the time between date of randomization to the date of first onset of partial response (PR) or better response. |
| Secondary | Duration of Response (DOR) using investigator's response assessment based on IMWG criteria | All patients treated for 6 cycles (cycle = 28 days) | DOR is defined as the duration from the first documented onset of PR or better response the date of first documented disease progression or death due to multiple myeloma. DOR will use only the patients with PR or better as their best response. |
| Secondary | Time to progression (TTP) using investigator's response assessment based on IMWG criteria | All patients treated for 6 cycles (cycle = 28 days) | TTP is defined as the time from the date of randomization to the ate of the first documented disease progression or death due to multiple myeloma. |
| Secondary | Time to reach Cmax for panobinostat (PAN) and carfilzomib (CFZ) | All patients treated for 6 cycles (cycle=28 days); | The maximum (peak) observed plasma concentration after single and multiple dose administration (ng/mL) of PAN and CFZ. |
| Secondary | Minimum observed plasma concentration (Cmin) for carfilzomib | All patients treated for 6 cycles (cycle=28 days) | The minimum (trough) observed plasma concentration after single and multiple dose administration (ng/mL) of PAN and CFZ. |
| Secondary | Concentration of panobinostat in blood plasma in 48 hrs after the dose. | All patients treated for 6 cycles (cycle = 28 days) | The area under the concentration-time curve (AUC) from time zero to 48 hours (ng\*h/mL) after the dose of PAN |
| Secondary | Total carfilzomib exposure over time in blood plasma . | All patients treated for 6 cycles (cycle=28 days) | The AUC from time zero to infinity (ng\*h/mL) for CFZ. |
| Secondary | Health related quality of life (HRQoL) change over time measured by EORTC questionnaire QLQ-C30 and QLQ-MY20 for disease symptoms | All patients treated for 6 cycles (cycle=28 days) | HRQoL questionnaires are patient reported outcomes, which provide functional assessment of cancer therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02756663/registered