Trial · NCT02303821
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Phase 1b: Maximum Concentration (Cmax) of Carfilzomib Alone and in Combination | Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15 minutes (m) after the start of infusion, immediately (within 2m) before the end of infusion (EOI), EOI, 10m, 30m, 1 hour (h), 2 h, and 4h post-dose | Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle. | ng/mL | MEAN |
| SECONDARY | Phase 1b: Area Under the Curve (AUC) From Time 0 to the Last Quantifiable Timepoint (AUClast) of Carfilzomib | Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose | Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle. | hr*ng/mL | MEAN |
| SECONDARY | Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib | Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose | Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle. | hr*ng/ mL | MEAN |
| SECONDARY | Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle | Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29) | Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle | Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29) | Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Number of Participants Who Experienced TEAEs | From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks | Phase 2 Safety Analysis Set: All participants enrolled to study 20140106 who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status | Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants]) | Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Event Free Survival (EFS) | Up to approximately 2 years | Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. | Months | MEDIAN |
| SECONDARY | Phase 2: Overall Survival (OS) | Up to approximately 2 years | Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. | Months | MEDIAN |
| SECONDARY | Phase 2: Duration of Remission (DOR) | Up to approximately 2 years | Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method. | Months | MEDIAN |
| SECONDARY | Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CR After Induction Therapy | Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants]) | Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Induction Therapy | Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants]) | Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy | Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants]) | Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants Who Underwent Stem Cell Transplant or Chimeric Antigen Receptor T-cell (CAR-T) Without Intervening Relapse Following Protocol-Specified Therapy | Up to approximately 2 years | Phase 2: Safety analysis set: All participants who received at least 1 dose of carfilzomib. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants With CRi or Better Remission Status After Consolidation Therapy | Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants]) | Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: AUClast of Carfilzomib | Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle) | Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell. | hr*ng/mL | MEAN |
| SECONDARY | Phase 2: AUCinf of Carfilzomib | Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle) | Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell. | hr*ng/mL | MEAN |
| SECONDARY | Phase 2: Cmax of Carfilzomib | Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle) | Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell. | ng/mL | MEAN |
| SECONDARY | Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib | Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle) | Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell. | hour | MEAN |
| PRIMARY | Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks | Phase 1b Safety Analysis Set: All participants who received any amount of the study treatment regimen. | Participants | COUNT_OF_PARTICIPANTS |
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.
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