TriangleNCT01432600 · OUTCOME
Phase II - Overall Response Rate (ORR)
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
- 36 Months
What was measured
Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.
Analysis population: All Phase II Participants.
Groups in this outcome
B: Pomalidomide and Dexamethasone
Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
C: Pomalidomide, Dexamethasone, Cyclophosphamide
Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
| Group | Source count |
|---|---|
| B: Pomalidomide and Dexamethasone | 36 |
| C: Pomalidomide, Dexamethasone, Cyclophosphamide | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| B: Pomalidomide and Dexamethasone | 38.9 | Not reported | 23 | 54.8 | Not reported |
| C: Pomalidomide, Dexamethasone, Cyclophosphamide | 64.7 | Not reported | 48.6 | 80.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 54.8
- value
- 38.9
- group Id
- OG001
- lower Limit
- 48.6
- upper Limit
- 80.8
- value
- 64.7
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
- id
- OG000
- title
- B: Pomalidomide and Dexamethasone
- description
- Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
- id
- OG001
- title
- C: Pomalidomide, Dexamethasone, Cyclophosphamide
- param Type
- NUMBER
- population Description
- All Phase II Participants.
- reporting Status
- POSTED
- time Frame
- 36 Months
- title
- Phase II - Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice