NCT00441168 · OUTCOME
Best Confirmed Disease Response
Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma · Source last updated 2014-03-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- every 28 days during treatment period for up to 6 to 8 cycles
What was measured
The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease \[PD\], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.
Analysis population: Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
Groups in this outcome
VAD Treatment
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
PAD Treatment
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| VAD Treatment | 15 |
|---|
| PAD Treatment | 13 |
|---|
Reported measurements
CR
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
PR
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Response Rate (CR + PR)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
MR
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Overall Response (CR + PR + MR)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
NC
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
PD
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Unknown/Unable to Assess
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| VAD Treatment | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| PAD Treatment | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- title
- Response Rate (CR + PR)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- title
- Overall Response (CR + PR + MR)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- title
- NC
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- title
- Unknown/Unable to Assess
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease \[PD\], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.
- groups
- description
- vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
- id
- OG000
- title
- VAD Treatment
- description
- bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
- id
- OG001
- title
- PAD Treatment
- param Type
- NUMBER
- population Description
- Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
- reporting Status
- POSTED
- time Frame
- every 28 days during treatment period for up to 6 to 8 cycles
- title
- Best Confirmed Disease Response
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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