TriangleNCT00644228 · OUTCOME
Response Rates ()
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 years
What was measured
The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.
Analysis population: All eligible, analyzable patients are included.
Groups in this outcome
Arm I (Dexamethasone and Lenalidomide)
Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
Arm II (Dexamethasone, Lenalidomide, Bortezomib)
Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
| Group | Source count |
|---|---|
| Arm I (Dexamethasone and Lenalidomide) | 229 |
| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 242 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Dexamethasone and Lenalidomide) | 153 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 176 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.20
- p Value Comment
- The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.20
- p Value Comment
- The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 176
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.
- groups
- description
- Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
- id
- OG000
- title
- Arm I (Dexamethasone and Lenalidomide)
- description
- Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
- id
- OG001
- title
- Arm II (Dexamethasone, Lenalidomide, Bortezomib)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible, analyzable patients are included.
- reporting Status
- POSTED
- time Frame
- Up to 6 years
- title
- Response Rates ()
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice