Trial · NCT02290431
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | Cmax: The maximum (peak) observed plasma concentration. 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. |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | Tmax: The time to reach maximum (peak) plasma concentration. 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. |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | T1/2: The elimination half-life associated with the terminal slope (Lambda\_z) of a semi logarithmic concentration-time curve |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | Lambda\_z: The terminal elimination rate constant (h-1) |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | CL/F: The apparent total body clearance of drug from the plasma |
| Secondary | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda\_z) |
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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