TriangleNCT01049945 · OUTCOME
Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).
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
- Up to 6 cycles of treatment
What was measured
Complete response (CR) \- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow Near complete response (nCR) A CR, with the persistence of original monoclonal protein Very good partial response (VGPR) \- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h Partial response (PR) * ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h. * a ≥50% decrease in the difference between involved and uninvolved FLC levels * or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.
Analysis population: All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.
Groups in this outcome
Maximum Tolerated Dose, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Maximum Tolerated Dose, Dose Level 4 | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maximum Tolerated Dose, Dose Level 4 | 44 | Not reported | 30 | 58 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 58
- value
- 44
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Complete response (CR) \- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow Near complete response (nCR) A CR, with the persistence of original monoclonal protein Very good partial response (VGPR) \- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h Partial response (PR) * ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h. * a ≥50% decrease in the difference between involved and uninvolved FLC levels * or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Maximum Tolerated Dose, Dose Level 4
- param Type
- NUMBER
- population Description
- All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.
- reporting Status
- POSTED
- time Frame
- Up to 6 cycles of treatment
- title
- Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice