TriangleNCT01731886 · OUTCOME
Complete Response 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
- 3 years
What was measured
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
Analysis population: 1 participant in Arm B never started treatment.
Groups in this outcome
Arm A: Low-dose Dexamethasone + Stem Cell Transplantation
Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
Arm B: Low-dose Dexamethasone
Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
| Group | Source count |
|---|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 31 |
| Arm B: Low-dose Dexamethasone | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Low-dose Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
- groups
- description
- Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
- id
- OG000
- title
- Arm A: Low-dose Dexamethasone + Stem Cell Transplantation
- description
- Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
- id
- OG001
- title
- Arm B: Low-dose Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 1 participant in Arm B never started treatment.
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Complete Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice