TriangleNCT01348919 · OUTCOME
Overall Response Rate (ORR) in Participants Treated at the (Maximum Tolerated Dose) MTD, as Assessed Using International Myeloma Working Group (IMWG) Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first administration of CEP-18770 up to approximately 1.5 years
What was measured
The ORR is defined as percentage of participants who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study. sCR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; \< 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; and absence of clonal cells in bone marrow. CR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; and \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; 90% or greater reduction in serum M-protein level and urine M-protein level less than 100 milligrams (mg)/24 hours. PR: ≥50% reduction in serum M-protein level; ≥90% reduction in 24-hour urinary M-protein level or reduction to less than 200 mg per 24 hours; and ≥50% reduction in the size of any soft tissue plasmacytomas present at baseline.
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.
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 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CEP-18770 Dose B | 40 | Not reported | 5.27 | 85.34 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.27
- upper Limit
- 85.34
- value
- 40
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The ORR is defined as percentage of participants who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study. sCR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; \< 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; and absence of clonal cells in bone marrow. CR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; and \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; 90% or greater reduction in serum M-protein level and urine M-protein level less than 100 milligrams (mg)/24 hours. PR: ≥50% reduction in serum M-protein level; ≥90% reduction in 24-hour urinary M-protein level or reduction to less than 200 mg per 24 hours; and ≥50% reduction in the size of any soft tissue plasmacytomas present at baseline.
- 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
- NUMBER
- 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.
- reporting Status
- POSTED
- time Frame
- From the first administration of CEP-18770 up to approximately 1.5 years
- title
- Overall Response Rate (ORR) in Participants Treated at the (Maximum Tolerated Dose) MTD, as Assessed Using International Myeloma Working Group (IMWG) Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice