TriangleNCT01484275 · OUTCOME
Progressive Disease Indicator Rate (PDIR) at 6 Months
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
- 95% Confidence Interval
- Time frame
- At 6 Months
What was measured
PDIR is defined as percentage of participants who meet any of following criteria occurring within 6 months of start of treatment. a) CRAB criteria: true progression events, b) Serum M-protein: increase by 25 % compared with baseline at 2 consecutive assessments, c) Magnetic resonance imaging: unequivocal increase in focal bone lesions, d) Immunoparesis: decrease by 25% compared with baseline of 2 other non-affected immunoglobulin (Ig) (IgG, IgM, IgA) at 2 consecutive assessments, e) Hemoglobin: decrease of 1.5 g/dL (with at least 1 read below LLN) at 2 consecutive assessments, with no other identifiable cause. PD is defined as presence of M-component in serum plus clonal plasma cells in bone marrow plus 1 or more of following: Calcium elevation (\> 11.5 mg/dL \[\> 2.88 mmol/L\]); Renal insufficiency (creatinine \>2 mg/dL \[177 micro mol/L or more\]); Anemia (hemoglobin \<10 or 2 g/dL lower than LLN) \[hemoglobin \< 6.5 or 1.25 mmol/L lower than LLN\]); Bone disease (lytic lesions or osteopenia).
Analysis population: Response evaluable population included participants who had a diagnosis of high-risk smoldering multiple myeloma (SMM) and received at least 1 dose of siltuximab/placebo treatment. In addition, participants were to have at least 1 post-baseline disease assessment.
Groups in this outcome
Siltuximab
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Placebo
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
| Group | Source count |
|---|---|
| Siltuximab | 43 |
| Placebo | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab | 30.2 | Not reported | 17.2 | 46.1 | Not reported |
| Placebo | 42.9 | Not reported | 27.7 | 59.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.2
- upper Limit
- 46.1
- value
- 30.2
- group Id
- OG001
- lower Limit
- 27.7
- upper Limit
- 59.0
- value
- 42.9
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- PDIR is defined as percentage of participants who meet any of following criteria occurring within 6 months of start of treatment. a) CRAB criteria: true progression events, b) Serum M-protein: increase by 25 % compared with baseline at 2 consecutive assessments, c) Magnetic resonance imaging: unequivocal increase in focal bone lesions, d) Immunoparesis: decrease by 25% compared with baseline of 2 other non-affected immunoglobulin (Ig) (IgG, IgM, IgA) at 2 consecutive assessments, e) Hemoglobin: decrease of 1.5 g/dL (with at least 1 read below LLN) at 2 consecutive assessments, with no other identifiable cause. PD is defined as presence of M-component in serum plus clonal plasma cells in bone marrow plus 1 or more of following: Calcium elevation (\> 11.5 mg/dL \[\> 2.88 mmol/L\]); Renal insufficiency (creatinine \>2 mg/dL \[177 micro mol/L or more\]); Anemia (hemoglobin \<10 or 2 g/dL lower than LLN) \[hemoglobin \< 6.5 or 1.25 mmol/L lower than LLN\]); Bone disease (lytic lesions or osteopenia).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
- id
- OG000
- title
- Siltuximab
- description
- Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Response evaluable population included participants who had a diagnosis of high-risk smoldering multiple myeloma (SMM) and received at least 1 dose of siltuximab/placebo treatment. In addition, participants were to have at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- At 6 Months
- title
- Progressive Disease Indicator Rate (PDIR) at 6 Months
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice