TriangleNCT01794039 · OUTCOME
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Analysis population: All patients that received treatment were evaluable for response
Groups in this outcome
Arm A (Lenalidomide, Dexamethasone)
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. \> \> Dexamethasone: Given PO \> \> Lenalidomide: Given PO
Arm B (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Dexamethasone: Given PO \> \> Pomalidomide: Given PO
| Group | Source count |
|---|---|
| Arm A (Lenalidomide, Dexamethasone) | 5 |
| Arm B (Pomalidomide, Dexamethasone) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide, Dexamethasone) | .4 | Not reported | .05 | .85 | Not reported |
| Arm B (Pomalidomide, Dexamethasone) | .25 | Not reported | .006 | .81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .05
- upper Limit
- .85
- value
- .4
- group Id
- OG001
- lower Limit
- .006
- upper Limit
- .81
- value
- .25
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. \> \> Dexamethasone: Given PO \> \> Lenalidomide: Given PO
- id
- OG000
- title
- Arm A (Lenalidomide, Dexamethasone)
- description
- Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Dexamethasone: Given PO \> \> Pomalidomide: Given PO
- id
- OG001
- title
- Arm B (Pomalidomide, Dexamethasone)
- param Type
- NUMBER
- population Description
- All patients that received treatment were evaluable for response
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice