TriangleNCT02316106 · OUTCOME
Percentage of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features
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
- From start of treatment (Cycle 1 Day 1) until PD or prior to any subsequent anti-Multiple myeloma therapy (up to 7.89 years)
What was measured
Percentage of participants with symptomatic multiple myeloma with adverse prognostic features were reported. The International Staging System (ISS) for multiple myeloma (MM) was based on serum beta-2 microglobulin (S beta-2M) and serum albumin; that is, participants progressed to symptomatic multiple myeloma (SymT MM) with stage III (S beta2M\>= 5.5 mg/L) of ISS, Participants progressed to SymT MM with adverse cytogenetic characteristics (ACC), participants progressed to SymT MM with stage III of ISS or adverse cytogenetic characteristics. Adverse cytogenetic characteristics included Fluorescence in situ hybridization (FISH) findings of del(17p13), t(14;16), t(4;14), amp(1q21) or karyotype findings of t(4;14), del(17p) or a combination of these.
Analysis population: ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS.
Groups in this outcome
Arm A (Long Intense)
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
Arm B (Intermediate)
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
Arm C (Short Intense)
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
| Group | Source count |
|---|---|
| Arm A (Long Intense) | 41 |
| Arm B (Intermediate) | 41 |
| Arm C (Short Intense) | 41 |
Reported measurements
Participants with stage III of ISS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Long Intense) | 2.4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Intermediate) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Short Intense) | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with ACC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Long Intense) | 19.5 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Intermediate) | 12.2 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Short Intense) | 9.8 | Not reported | Not reported | Not reported | Not reported |
Participants with stage III of ISS staging or ACC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Long Intense) | 22.0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Intermediate) | 12.2 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Short Intense) | 9.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Participants with stage III of ISS
- categories
- measurements
- group Id
- OG000
- value
- 19.5
- group Id
- OG001
- value
- 12.2
- group Id
- OG002
- value
- 9.8
- title
- Participants with ACC
- categories
- measurements
- group Id
- OG000
- value
- 22.0
- group Id
- OG001
- value
- 12.2
- group Id
- OG002
- value
- 9.8
- title
- Participants with stage III of ISS staging or ACC
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 41
- units
- Participants
- description
- Percentage of participants with symptomatic multiple myeloma with adverse prognostic features were reported. The International Staging System (ISS) for multiple myeloma (MM) was based on serum beta-2 microglobulin (S beta-2M) and serum albumin; that is, participants progressed to symptomatic multiple myeloma (SymT MM) with stage III (S beta2M\>= 5.5 mg/L) of ISS, Participants progressed to SymT MM with adverse cytogenetic characteristics (ACC), participants progressed to SymT MM with stage III of ISS or adverse cytogenetic characteristics. Adverse cytogenetic characteristics included Fluorescence in situ hybridization (FISH) findings of del(17p13), t(14;16), t(4;14), amp(1q21) or karyotype findings of t(4;14), del(17p) or a combination of these.
- groups
- description
- Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
- id
- OG000
- title
- Arm A (Long Intense)
- description
- Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
- id
- OG001
- title
- Arm B (Intermediate)
- description
- Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
- id
- OG002
- title
- Arm C (Short Intense)
- param Type
- NUMBER
- population Description
- ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS.
- reporting Status
- POSTED
- time Frame
- From start of treatment (Cycle 1 Day 1) until PD or prior to any subsequent anti-Multiple myeloma therapy (up to 7.89 years)
- title
- Percentage of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice