TriangleNCT00098475 · OUTCOME
Proportion of Patients With Objective Response (First Phase, Step 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 4 weeks for 16 weeks during Step 1
What was measured
Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
Analysis population: Only eligible patients were included in this analysis.
Groups in this outcome
Arm I (Lenalidomide, Dexamethasone)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
Arm II (Lenalidomide, Low-dose Dexamethasone)
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
| Group | Source count |
|---|---|
| Arm I (Lenalidomide, Dexamethasone) | 214 |
| Arm II (Lenalidomide, Low-dose Dexamethasone) | 208 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Lenalidomide, Dexamethasone) | 0.79 | Not reported | 0.729 | 0.842 | Not reported |
| Arm II (Lenalidomide, Low-dose Dexamethasone) | 0.683 | Not reported | 0.615 | 0.745 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.052
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.162
- group Description
- The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- param Type
- Difference in response rate between arms
- param Value
- 0.107
Complete source fields
- analyses
- ci Lower Limit
- 0.052
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.162
- group Description
- The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- param Type
- Difference in response rate between arms
- param Value
- 0.107
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.729
- upper Limit
- 0.842
- value
- 0.79
- group Id
- OG001
- lower Limit
- 0.615
- upper Limit
- 0.745
- value
- 0.683
- denoms
- counts
- group Id
- OG000
- value
- 214
- group Id
- OG001
- value
- 208
- units
- Participants
- description
- Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
- id
- OG000
- title
- Arm I (Lenalidomide, Dexamethasone)
- description
- Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
- id
- OG001
- title
- Arm II (Lenalidomide, Low-dose Dexamethasone)
- param Type
- NUMBER
- population Description
- Only eligible patients were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every 4 weeks for 16 weeks during Step 1
- title
- Proportion of Patients With Objective Response (First Phase, Step 1)
- type
- PRIMARY
- unit Of Measure
- Proportion of patients
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Preserved source evidence · Not medical advice