TriangleNCT00555906 · OUTCOME
Duration of Objective Response (DR): Phase 2
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
- Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib
What was measured
DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, \>=90% reduction in serum M-protein, \<100 mg/24hr urine M-protein. PR:\>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200 mg/24 hr. PD: \>=25% increase from lowest response level in serum M-component, urine M-component, \>=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
Analysis population: PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.
Groups in this outcome
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
| Group | Source count |
|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 4.63 | Not reported | 1.643 | NA | Upper limit of 95% could not be estimated since very few number of participants had response. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% could not be estimated since very few number of participants had response.
- group Id
- OG000
- lower Limit
- 1.643
- upper Limit
- NA
- value
- 4.63
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, \>=90% reduction in serum M-protein, \<100 mg/24hr urine M-protein. PR:\>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200 mg/24 hr. PD: \>=25% increase from lowest response level in serum M-component, urine M-component, \>=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
- id
- OG000
- title
- Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
- param Type
- MEDIAN
- population Description
- PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib
- title
- Duration of Objective Response (DR): Phase 2
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice