TriangleNCT00648739 · OUTCOME
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
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
- From first dose through 10 weeks after the last dose
What was measured
Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.
Analysis population: All participants with MM who received at least 1 dose of samalizumab.
Groups in this outcome
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
| Group | Source count |
|---|---|
| Samalizumab 500 mg/m^2 | 2 |
| Samalizumab 600 mg/m^2 | 1 |
Reported measurements
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 500 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
ORR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- ORR
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.
- groups
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG000
- title
- Samalizumab 500 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG001
- title
- Samalizumab 600 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants with MM who received at least 1 dose of samalizumab.
- reporting Status
- POSTED
- time Frame
- From first dose through 10 weeks after the last dose
- title
- Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice