TriangleNCT01248455 · OUTCOME
Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- 1 year
What was measured
Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \>25% and \<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium \>2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin \<10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.
Analysis population: Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).
Groups in this outcome
Anti-KIR in Smoldering Multiple Myeloma Patients
Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
| Group | Source count |
|---|---|
| Anti-KIR in Smoldering Multiple Myeloma Patients | 9 |
Reported measurements
Minimal Response (MR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anti-KIR in Smoldering Multiple Myeloma Patients | 11 | Not reported | Not reported | Not reported | Not reported |
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anti-KIR in Smoldering Multiple Myeloma Patients | 66 | Not reported | Not reported | Not reported | Not reported |
Biochemical Progression (BP)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anti-KIR in Smoldering Multiple Myeloma Patients | 11 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anti-KIR in Smoldering Multiple Myeloma Patients | 11 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Description
- No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.56
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Description
- No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.56
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Minimal Response (MR)
- categories
- measurements
- group Id
- OG000
- value
- 66
- title
- Stable Disease (SD)
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Biochemical Progression (BP)
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Progressive Disease (PD)
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \>25% and \<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium \>2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin \<10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.
- groups
- description
- Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
- id
- OG000
- title
- Anti-KIR in Smoldering Multiple Myeloma Patients
- param Type
- NUMBER
- population Description
- Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice