NCT01852799 · OUTCOME
Bone Formation Markers Measurement
A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma · Source last updated 2018-08-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- U/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Cycle 4 with 28 days per cycle
What was measured
The bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）are measured on serum samples by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative multiple myeloma(MM) treatment, if earlier.
Groups in this outcome
PAD Followed by ASCT
Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)
Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)
Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
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 |
|---|
| PAD Followed by ASCT | 18 |
|---|
Reported measurements
bALP on baseline
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 21.87 | 14.11 | Not reported | Not reported | Not reported |
|---|
bALP after cycle 1
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 23.2 | 12.89 | Not reported | Not reported | Not reported |
|---|
bALP changes from baseline to cycle 1
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 1.33 | 1.02 | Not reported | Not reported | Not reported |
|---|
bALP after cycle 4
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 28.75 | 13.12 | Not reported | Not reported | Not reported |
|---|
bALP changes from baseline to cycle 4
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 6.88 | 3.20 | Not reported | Not reported | Not reported |
|---|
DKK-1 on baseline
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 4765 | 159.5 | Not reported | Not reported | Not reported |
|---|
DKK-1 aftercycle 1
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 2653 | 135.2 | Not reported | Not reported | Not reported |
|---|
DKK-1 changes from baseline to cycle 1
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 2653 | 135.2 | Not reported | Not reported | Not reported |
|---|
DKK-1 after cycle 4
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 1589 | 128.2 | Not reported | Not reported | Not reported |
|---|
DKK-1 changes from baseline to cycle 4
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PAD Followed by ASCT | 3176 | 123.8 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- bALP changes from baseline to cycle 1
- non Inferiority Type
- OTHER
- p Value
- 0.002
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- b-ALP changes from baseline to cycle 4
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- t-test, 2 sided
- group Description
- DKK-1 changes from baseline to cycle 1
- non Inferiority Type
- OTHER
- p Value
- 0.005
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- DKK-1 changes from baseline to cycle 4
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Description
- bALP changes from baseline to cycle 1
- non Inferiority Type
- OTHER
- p Value
- 0.002
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- b-ALP changes from baseline to cycle 4
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- t-test, 2 sided
- group Description
- DKK-1 changes from baseline to cycle 1
- non Inferiority Type
- OTHER
- p Value
- 0.005
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- DKK-1 changes from baseline to cycle 4
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14.11
- value
- 21.87
- title
- bALP on baseline
- categories
- measurements
- group Id
- OG000
- spread
- 12.89
- value
- 23.2
- title
- bALP after cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 1.02
- value
- 1.33
- title
- bALP changes from baseline to cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 13.12
- value
- 28.75
- title
- bALP after cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 3.20
- value
- 6.88
- title
- bALP changes from baseline to cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 159.5
- value
- 4765
- title
- DKK-1 on baseline
- categories
- measurements
- group Id
- OG000
- spread
- 135.2
- value
- 2653
- title
- DKK-1 aftercycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 135.2
- value
- 2653
- title
- DKK-1 changes from baseline to cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 128.2
- value
- 1589
- title
- DKK-1 after cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 123.8
- value
- 3176
- title
- DKK-1 changes from baseline to cycle 4
- description
- The bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）are measured on serum samples by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative multiple myeloma(MM) treatment, if earlier.
- dispersion Type
- Standard Deviation
- groups
- description
- Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)
Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)
Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
- id
- OG000
- title
- PAD Followed by ASCT
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Up to Cycle 4 with 28 days per cycle
- title
- Bone Formation Markers Measurement
- type
- PRIMARY
- unit Of Measure
- U/L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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