TriangleNCT02765854 · OUTCOME
The Primary Objective of the Study is to Test Whether the NFKB2 Rearrangement Can Guide the Selection of Treatment (Ixazomib Plus Dexamethasone (Id) or Ixazomib Plus Lenalidomide and Dexamethasone (IRd)) by Conducting the 3 Following Comparisons
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
- 112 days
What was measured
Comparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance of +/- 20% when the true RR of Arm B is approximately 30%. Response Rate is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Groups in this outcome
Arm B (Ixazomib and Dexamethasone)
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO
Arm A (Ixazomib and Dexamethasone)
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO
| Group | Source count |
|---|---|
| Arm B (Ixazomib and Dexamethasone) | 22 |
| Arm C (Ixazomib, Dexamethasone, Lenalidomide) | 21 |
| Arm A (Ixazomib and Dexamethasone) | 27 |
Reported measurements
Yes: Response Achieved at Four Cycles
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Ixazomib and Dexamethasone) | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Ixazomib, Dexamethasone, Lenalidomide) | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm A (Ixazomib and Dexamethasone) | 16 | Not reported | Not reported | Not reported | Not reported |
No: Response Achieved at Four Cycles
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Ixazomib and Dexamethasone) | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Ixazomib, Dexamethasone, Lenalidomide) | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm A (Ixazomib and Dexamethasone) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 16
- title
- Yes: Response Achieved at Four Cycles
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- title
- No: Response Achieved at Four Cycles
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 27
- units
- Participants
- description
- Comparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance of +/- 20% when the true RR of Arm B is approximately 30%. Response Rate is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- groups
- description
- MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO
- id
- OG000
- title
- Arm B (Ixazomib and Dexamethasone)
- description
- MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO
- id
- OG001
- title
- Arm C (Ixazomib, Dexamethasone, Lenalidomide)
- description
- UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO
- id
- OG002
- title
- Arm A (Ixazomib and Dexamethasone)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 112 days
- title
- The Primary Objective of the Study is to Test Whether the NFKB2 Rearrangement Can Guide the Selection of Treatment (Ixazomib Plus Dexamethasone (Id) or Ixazomib Plus Lenalidomide and Dexamethasone (IRd)) by Conducting the 3 Following Comparisons
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice