TriangleNCT00807599 · OUTCOME
Number of Participants With VGPR + CR Rate
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
- 2 years
What was measured
VGPR/Very Good Partial Response + CR/Complete Response (\>/= VGPR) for each study arm Per 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
Continue Lenalidomide and Dexamethasone
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection * continue lenalidomide and dexamethasone * saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
Stem Cell Transplant x 1 or x 2
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : * stem cell transplant right after collection * continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
| Group | Source count |
|---|---|
| Continue Lenalidomide and Dexamethasone | 26 |
| Stem Cell Transplant x 1 or x 2 | 24 |
Reported measurements
Source class 1
>/= VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Continue Lenalidomide and Dexamethasone | 18 | Not reported | Not reported | Not reported | Not reported |
| Stem Cell Transplant x 1 or x 2 | 21 | Not reported | Not reported | Not reported | Not reported |
<VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Continue Lenalidomide and Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Stem Cell Transplant x 1 or x 2 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 21
- title
- >/= VGPR
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 3
- title
- <VGPR
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- VGPR/Very Good Partial Response + CR/Complete Response (\>/= VGPR) for each study arm Per 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
- All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection * continue lenalidomide and dexamethasone * saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
- id
- OG000
- title
- Continue Lenalidomide and Dexamethasone
- description
- All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : * stem cell transplant right after collection * continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
- id
- OG001
- title
- Stem Cell Transplant x 1 or x 2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Number of Participants With VGPR + CR Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice