TriangleNCT01054144 · OUTCOME
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
- Every 8 weeks up to 12 months
What was measured
Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).
Analysis population: 1 participant could not be evaluated for response.
Groups in this outcome
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Single Agent Lenalidomide
Participants treated with single agent lenalidomide
| Group | Source count |
|---|---|
| Response Adapted Therapy | 9 |
| Single Agent Lenalidomide | 26 |
Reported measurements
Complete Response & Stringent Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 4 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 3 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 12 | Not reported | Not reported | Not reported | Not reported |
Minimal Response (MR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 5 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 4 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 3 | Not reported | Not reported | Not reported | Not reported |
Overall Response >/= PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Response Adapted Therapy | 4 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Lenalidomide | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- title
- Complete Response & Stringent Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- Very Good Partial Response (VGPR)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 12
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- title
- Minimal Response (MR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 19
- title
- Overall Response >/= PR
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).
- groups
- description
- Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
- id
- OG000
- title
- Response Adapted Therapy
- description
- Participants treated with single agent lenalidomide
- id
- OG001
- title
- Single Agent Lenalidomide
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 1 participant could not be evaluated for response.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks up to 12 months
- title
- Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice