TriangleNCT03951220 · OUTCOME
Primary Outcome 1: Quantifying Tumour Burden (Correlations With Bone Turnover Markers)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Spearman's rank correlation coefficient
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At baseline
What was measured
Primary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone. This section examined correlation between baseline bone biomarkers and baseline serum paraprotein in a pooled cohort of patients from Groups 1 and 2, using Spearman's Rank Correlation Coefficients.
Analysis population: Pooled cohort of patients from Groups 1 and 2 who had measured: i) available baseline serum paraprotein; ii) by baseline bone biomarkers.
Groups in this outcome
Baseline P1NP
Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).
Baseline CTX-1
Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
Baseline ALP
Baseline measurements of ALP (Alkaline Phosphatase).
Baseline DKK1
Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
Baseline Sclerostin
Baseline measurements of sclerostin.
Baseline RANKL:OPG
Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).
| Group | Source count |
|---|---|
| Baseline P1NP | 28 |
| Baseline CTX-1 | 28 |
| Baseline ALP | 28 |
| Baseline DKK1 | 28 |
| Baseline Sclerostin | 28 |
| Baseline RANKL:OPG | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baseline P1NP | 0.31 | Not reported | -0.10 | 0.64 | Not reported |
| Baseline CTX-1 | 0.01 | Not reported | -0.41 | 0.42 | Not reported |
| Baseline ALP | -0.18 | Not reported | -0.54 | 0.24 | Not reported |
| Baseline DKK1 | 0.39 | Not reported | 0.00 | 0.68 | Not reported |
| Baseline Sclerostin | 0.23 | Not reported | -0.17 | 0.57 | Not reported |
| Baseline RANKL:OPG | -0.02 | Not reported | -0.42 | 0.38 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.68
- group Ids
- OG003
- non Inferiority Comment
- Correlation
- non Inferiority Type
- OTHER
- p Value
- 0.0445
- param Type
- Spearman (r)
- param Value
- 0.39
- statistical Method
- Spearman's rank correlation coeffcieitn
Complete source fields
- analyses
- ci Lower Limit
- 0.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.68
- group Ids
- OG003
- non Inferiority Comment
- Correlation
- non Inferiority Type
- OTHER
- p Value
- 0.0445
- param Type
- Spearman (r)
- param Value
- 0.39
- statistical Method
- Spearman's rank correlation coeffcieitn
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.10
- upper Limit
- 0.64
- value
- 0.31
- group Id
- OG001
- lower Limit
- -0.41
- upper Limit
- 0.42
- value
- 0.01
- group Id
- OG002
- lower Limit
- -0.54
- upper Limit
- 0.24
- value
- -0.18
- group Id
- OG003
- lower Limit
- 0.00
- upper Limit
- 0.68
- value
- 0.39
- group Id
- OG004
- lower Limit
- -0.17
- upper Limit
- 0.57
- value
- 0.23
- group Id
- OG005
- lower Limit
- -0.42
- upper Limit
- 0.38
- value
- -0.02
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 28
- units
- Participants
- description
- Primary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone. This section examined correlation between baseline bone biomarkers and baseline serum paraprotein in a pooled cohort of patients from Groups 1 and 2, using Spearman's Rank Correlation Coefficients.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).
- id
- OG000
- title
- Baseline P1NP
- description
- Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
- id
- OG001
- title
- Baseline CTX-1
- description
- Baseline measurements of ALP (Alkaline Phosphatase).
- id
- OG002
- title
- Baseline ALP
- description
- Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
- id
- OG003
- title
- Baseline DKK1
- description
- Baseline measurements of sclerostin.
- id
- OG004
- title
- Baseline Sclerostin
- description
- Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).
- id
- OG005
- title
- Baseline RANKL:OPG
- param Type
- NUMBER
- population Description
- Pooled cohort of patients from Groups 1 and 2 who had measured: i) available baseline serum paraprotein; ii) by baseline bone biomarkers.
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Primary Outcome 1: Quantifying Tumour Burden (Correlations With Bone Turnover Markers)
- type
- PRIMARY
- unit Of Measure
- Spearman's rank correlation coefficient
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice