TriangleNCT00849251 · OUTCOME
Disease Response Rate (Cohort II)
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
- up to 28 days after last cycle of treatment
What was measured
Disease response using Blade Multiple Myeloma Response Criteria in newly diagnosed (Cohort II) patients who completed at least one cycle of treatment. There were 24 evaluable patients in Cohort II.
Analysis population: Newly diagnosed patients (cohort II)
Groups in this outcome
Newly Diagnosed Patients
Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV or PO pegylated liposomal doxorubicin hydrochloride: Given IV bortezomib: Given IV dexamethasone: Given IV or PO
| Group | Source count |
|---|---|
| Newly Diagnosed Patients | 24 |
Reported measurements
Source class 1
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Newly Diagnosed Patients | 2 | Not reported | Not reported | Not reported | Not reported |
Near complete response (nCR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Newly Diagnosed Patients | 2 | Not reported | Not reported | Not reported | Not reported |
Very good partial response (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Newly Diagnosed Patients | 3 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Newly Diagnosed Patients | 11 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Newly Diagnosed Patients | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 2
- title
- Near complete response (nCR)
- measurements
- group Id
- OG000
- value
- 3
- title
- Very good partial response (VGPR)
- measurements
- group Id
- OG000
- value
- 11
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 6
- title
- Stable disease (SD)
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- Disease response using Blade Multiple Myeloma Response Criteria in newly diagnosed (Cohort II) patients who completed at least one cycle of treatment. There were 24 evaluable patients in Cohort II.
- groups
- description
- Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV or PO pegylated liposomal doxorubicin hydrochloride: Given IV bortezomib: Given IV dexamethasone: Given IV or PO
- id
- OG000
- title
- Newly Diagnosed Patients
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Newly diagnosed patients (cohort II)
- reporting Status
- POSTED
- time Frame
- up to 28 days after last cycle of treatment
- title
- Disease Response Rate (Cohort II)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice