TriangleNCT03951220 · OUTCOME
Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Pearson's 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 particular section analysed the correlation between the Apparent Diffusion Coefficient (ADC) measurements (from the Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) component of the sequences) of lytic bone lesions, with standard clinical correlates of tumour burden (serum paraprotein, and serum paraprotein-associated immunoglobulin level). The measurement of ADC from DW-MRI is further described by Messiou et. al. \[1\] \[1\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.
Analysis population: Subset of Group 1a and 1b, on active chemotherapy, with lytic bone lesions identified on baseline novel MR scan, amenable to ADC measurement, and a paired baseline serum paraprotein, or paraprotein-associated immunoglobulin, level available (where measurement was unsuccessful the number analysed is lower than the overall number analysed). Group 1c, 2 and 3 participants did not have a lytic bone lesion identified on novel MR scan, and were therefore not included in the analysis.
Groups in this outcome
Group 1a: New Myeloma
All patients with new myeloma at recruitment.
Group 1b: Relapsed Myeloma
All patients with relapsed myeloma at recruitment.
| Group | Source count |
|---|---|
| Group 1a: New Myeloma | 11 |
| Group 1b: Relapsed Myeloma | 3 |
Reported measurements
ADC vs serum paraprotein
| Group | Source count |
|---|---|
| Group 1a: New Myeloma | 4 |
| Group 1b: Relapsed Myeloma | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1a: New Myeloma | -0.66 | Not reported | -0.99 | 0.82 | Not reported |
| Group 1b: Relapsed Myeloma | NA | Not reported | NA | NA | Only one data point, so not amenable to Pearson's correlation coefficient |
ADC vs serum paraprotein-associated immunoglobulin level
| Group | Source count |
|---|---|
| Group 1a: New Myeloma | 9 |
| Group 1b: Relapsed Myeloma | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1a: New Myeloma | -0.28 | Not reported | -0.79 | 0.48 | Not reported |
| Group 1b: Relapsed Myeloma | 0.48 | Not reported | NA | NA | Only three data points, hence 95% confidence interval cannot be reliably calculated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.99
- upper Limit
- 0.82
- value
- -0.66
- comment
- Only one data point, so not amenable to Pearson's correlation coefficient
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- ADC vs serum paraprotein
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.79
- upper Limit
- 0.48
- value
- -0.28
- comment
- Only three data points, hence 95% confidence interval cannot be reliably calculated.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.48
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- ADC vs serum paraprotein-associated immunoglobulin level
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 3
- 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 particular section analysed the correlation between the Apparent Diffusion Coefficient (ADC) measurements (from the Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) component of the sequences) of lytic bone lesions, with standard clinical correlates of tumour burden (serum paraprotein, and serum paraprotein-associated immunoglobulin level). The measurement of ADC from DW-MRI is further described by Messiou et. al. \[1\] \[1\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients with new myeloma at recruitment.
- id
- OG000
- title
- Group 1a: New Myeloma
- description
- All patients with relapsed myeloma at recruitment.
- id
- OG001
- title
- Group 1b: Relapsed Myeloma
- param Type
- NUMBER
- population Description
- Subset of Group 1a and 1b, on active chemotherapy, with lytic bone lesions identified on baseline novel MR scan, amenable to ADC measurement, and a paired baseline serum paraprotein, or paraprotein-associated immunoglobulin, level available (where measurement was unsuccessful the number analysed is lower than the overall number analysed). Group 1c, 2 and 3 participants did not have a lytic bone lesion identified on novel MR scan, and were therefore not included in the analysis.
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]
- type
- PRIMARY
- unit Of Measure
- Pearson's correlation coefficient
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Preserved source evidence · Not medical advice