TriangleNCT01348919 · OUTCOME
Duration of Response (DOR) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of first response to the date of disease progression (up to approximately 1.5 years)
What was measured
DOR was defined as the time interval from the date of first response (sCR, CR, VGPR, or PR) to the date of disease progression. sCR, CR, VGPR, and PR as defined in outcome measure 1. Disease progression was defined as any 1 or more of the following: Increase of 25% or more from lowest response level in any 1 or more of the following: - serum M-component (absolute increase must be ≥0.5 grams \[g\]/deciliter \[dL\]), - urine M-component (absolute increase must be ≥200 mg/24 hours), bone marrow plasma cell percentage ≥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; and development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to the plasma cell proliferation disorder.
Analysis population: The full analysis set included all participants who received at least 1 dose of CEP-18770 at the MTD, including participants treated at the MTD of CEP-18770 in Part 1 and who had at least 1 response assessment, or who discontinued treatment due to toxicity or death. Participants who did not have a response assessment were considered non-responders. Overall number of participants analyzed = participants with a response of sCR, CR, VGPR, or PR.
Groups in this outcome
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| CEP-18770 Dose B | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CEP-18770 Dose B | NA | Not reported | NA | NA | No participants with a response had an event of disease progression or death, hence the data could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- comment
- No participants with a response had an event of disease progression or death, hence the data could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- DOR was defined as the time interval from the date of first response (sCR, CR, VGPR, or PR) to the date of disease progression. sCR, CR, VGPR, and PR as defined in outcome measure 1. Disease progression was defined as any 1 or more of the following: Increase of 25% or more from lowest response level in any 1 or more of the following: - serum M-component (absolute increase must be ≥0.5 grams \[g\]/deciliter \[dL\]), - urine M-component (absolute increase must be ≥200 mg/24 hours), bone marrow plasma cell percentage ≥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; and development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to the plasma cell proliferation disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- CEP-18770 Dose B
- param Type
- MEDIAN
- population Description
- The full analysis set included all participants who received at least 1 dose of CEP-18770 at the MTD, including participants treated at the MTD of CEP-18770 in Part 1 and who had at least 1 response assessment, or who discontinued treatment due to toxicity or death. Participants who did not have a response assessment were considered non-responders. Overall number of participants analyzed = participants with a response of sCR, CR, VGPR, or PR.
- reporting Status
- POSTED
- time Frame
- From the date of first response to the date of disease progression (up to approximately 1.5 years)
- title
- Duration of Response (DOR) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice