Trial results for a study developing and pilot testing a new MR imaging protocol to quantify myeloma disease burden and bone loss were posted on ClinicalTrials.gov on 2025-08-19, involving 67 participants with Multiple Myeloma.
Background
Multiple Myeloma is a cancer of plasma cells, often preceded by Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smouldering Myeloma. Accurate quantification of tumor burden and bone loss is crucial for diagnosis, monitoring disease progression, and evaluating treatment efficacy. Current imaging techniques have limitations, and there is a need for improved methods to detect longitudinal changes in tumor load and bone microarchitecture with therapy. This study aimed to develop and assess a Magnetic Resonance (MR) imaging protocol to address these challenges, including investigating whether bone loss assessment differs between imaging techniques like DXA and Diffusion-Weighted Magnetic Resonance Imaging (DWMRI).
Trial design
This completed study enrolled 67 participants to develop and pilot a Magnetic Resonance (MR) imaging protocol. The conditions investigated included Myeloma, Monoclonal Gammopathy of Undetermined Significance (MGUS), and Smouldering Myeloma. The primary aims were to quantify tumor burden and bone loss, detect longitudinal changes in tumor load and microarchitecture with therapy, and correlate DXA imaging data with DWMRI.
Key results
The trial reported several key measurements and analyses related to quantifying tumor burden:
- Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements] (Pearson's correlation coefficient):
- For Group 1a: New Myeloma, a correlation coefficient of -0.66 was observed.
- For Group 1b: Relapsed Myeloma, the correlation coefficient was NA.
- Another measurement for Group 1a: New Myeloma showed a correlation coefficient of -0.28.
- Another measurement for Group 1b: Relapsed Myeloma showed a correlation coefficient of 0.48.
- Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease] (grams per liter (g/L)):
- For MY-RADS: Normal, the mean was 13.1 (Standard Deviation 9.4).
- For MY-RADS: Focal, the mean was 11.7 (Standard Deviation 7.8).
- For MY-RADS: Micronodular, the mean was 5.4 (Standard Deviation NA).
- For MY-RADS: Not Determined, the mean was 17.2 (Standard Deviation NA).
- Quantifying Tumour Burden (Correlations With Bone Turnover Markers) (Spearman's rank correlation coefficient):
- Baseline P1NP showed a correlation coefficient of 0.31.
- Baseline CTX-1 showed a correlation coefficient of 0.01.
- Baseline ALP showed a correlation coefficient of -0.18.
- Baseline DKK1 showed a correlation coefficient of 0.39.
Key analyses included:
- An ANOVA method yielded a p-value of 0.7343.
- A Spearman's rank correlation coefficient method for Spearman (r) 0.39 had a p-value of 0.0445, with a 95.0% Confidence Interval of [0.0, 0.68].
- A Kruskal-Wallis method for baseline P1NP showed a p-value of 0.0079.
- An ANOVA method for baseline sclerostin showed a p-value of 0.0482.
- A Fisher-Freeman-Halton exact test yielded a p-value of 0.015.
- A Mann-Whitney test yielded a p-value of 0.007.
What this means
The results from this pilot study provide valuable data on the utility of a new MR imaging protocol for quantifying tumor burden and bone loss in patients with Multiple Myeloma, MGUS, and Smouldering Myeloma. The reported correlations and specific measurements for ADC, MY-RADS patterns, and bone turnover markers offer insights into the protocol's potential for assessing disease activity. The statistically significant p-values from various analyses, such as Spearman's correlation for DKK1, Kruskal-Wallis for baseline P1NP, and ANOVA for baseline sclerostin, suggest that the MR protocol may be a useful tool for monitoring disease progression and treatment response. These findings can inform the development of more precise diagnostic and monitoring strategies for myeloma patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03951220, titled "The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss", were posted on 2025-08-19 on clinicaltrials.gov.