Trial · NCT03068351
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose-Limiting Toxicities (DLTs) | From first drug administration to end of dose-escalation phase (up to approximately 1 year) | DLTs are defined as the toxicities known and expected of RO6870810 and daratumumab that occur during a DLT assessment window of 21 days from the first administration of RO6870810 or study combination treatments, and are considered by the Investigator to be related to study treatment. DLTs are defined at specific severity levels for each term and include, but are not limited to the following Common Terminology Criteria for Adverse Events (CTCAE) terms: neutropenia, febrile neutropenia, thrombocytopenia, anemia and injection site reaction. |
| Primary | Objective Response Rate (ORR) | From baseline to end of study (up to approximately 2.5 years) | ORR is defined as the percentage of participants whose confirmed best overall response is either complete response (CR, including stringent complete response \[sCR\]) or partial response (PR, including very good partial response \[VGPR\]), assessed with use of the IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR: CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. PR: \>/=50% reduction of serum M-protein plus reduction in 24h urinary M-protein by \>/=90% or to \<200 mg/24h. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>/=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24h. ORR= CR + sCR + PR + VGPR |
| Primary | Progression Free Survival (PFS) | From baseline to end of study (up to approximately 2.5 years) | PFS is defined as the time from first study treatment to the first occurrence of disease progression (per IMWG criteria) or death, whichever occurs first. Disease progression is defined as an increase of \>/= 25% from lowest response value in any one or more of the following: serum M-component, urine M-component, in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (the absolute increase must be \>10 mg/dL), bone marrow plasma cell percentage (absolute level \>/= 10%), definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. |
| Primary | Duration of Response (DoR) | From baseline to end of study (up to approximately 2.5 years) | DoR is defined as the time from the first occurrence of a documented objective response (sCR, CR, VGPR, or PR) to the time of first disease progression per IMWG criteria or death from any cause, whichever occurs first. Disease progression is defined as an increase of \>/= 25% from lowest response value in any one or more of the following: serum M-component, urine M-component, in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (the absolute increase must be \>10 mg/dL), bone marrow plasma cell percentage (absolute level \>/= 10%), definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. |
| Primary | Overall survival (OS) | From baseline to end of study (up to approximately 2.5 years) | OS is defined as the time from study enrollment until death from any cause. |
| Secondary | Percentage of Participants with Adverse Events | From baseline to end of study (up to approximately 2.5 years) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 hours (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT- up to approximately 2.5 years) | Maximum observed concentration of RO6870810 as determined by measuring drug concentration in blood samples over time. |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (tmax) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT - up to approximately 2.5 years) | Time from dose administration to observed maximum serum concentration for RO6870810 as determined by measuring drug concentration in blood samples over time. |
| Secondary | Apparent Plasma Clearance (CL/F) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT - up to approximately 2.5 years) | Apparent clearance (CL/F) of RO6870810, where CL is clearance and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged). Determined by measuring drug concentration in blood samples over time. |
| Secondary | Apparent Volume of Distribution (V/F) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT - up to approximately 2.5 years) | Apparent volume of distribution (V/F) for RO6870810, where V is the volume of distribution and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged). Determined by measuring drug concentration in blood samples over time. |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT - up to approximately 2.5 years) | AUC for RO6870810 describes the extent of absorption from time of dose administration to time of sampling as determined by measuring drug concentration in blood samples over time. |
| Secondary | Half-life (t1/2) of RO6870810 | Cycle 1, Days 1 and 15: predose, 0.25 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 24 h, 48 h; Cycle 1, Day 8 predose; all subsequent cycles predose on Day 1 and at end of treatment (EOT - up to approximately 2.5 years) | Half-life of RO6870810 is the time elapsed for the drug concentration to decrease by half as determined by measuring drug concentration in blood samples over time. |
| Secondary | Renal Clearance (CLr) of RO6870810 | Cycle 1, Day 1: predose, 0-1 h, 1-4 h, 4-8 h; Cycle 1, Day 15: predose, 0 h, 2 h, 6 h | Clearance of RO6870810 through the kidneys as determined by measuring drug concentration in urine samples over time. |
| Secondary | M-Protein Levels | At baseline, end of study (up to approximately 2.5 years) | M-protein levels pre- and post-treatment will be monitored as a measure of biological response. |
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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