Cardiovascular

Phase 2 Trial of 89Zr-Deferoxamine-Daratumumab for CD38-targeted Immuno-PET/CT Detection of Multiple Myeloma.

Ulaner G, Kuker R, et al. • Radiology • 2026

PubMed 42975307 DOI 10.1148/radiol.260517

TL;DR

In participants with MM, CD38-targeted 89Zr-DFO-daratumumab immuno-PET helped detect active myeloma in some participants with no signs of disease at 18F-FDG PET/CT, although overall disease detection did not differ between the two modalities.

Key Findings

Results

89Zr-DFO-daratumumab PET/CT showed at least one positive lesion in 43% of participants with multiple myeloma.

26 of 60 participants were positive (95% CI: 31, 57).
Prospective phase 2 trial with accrual between March 2022 and July 2025.
Participants had a median age of 63 years (IQR, 57-71 years); 32 were women.

Results

Standard-of-care 18F-FDG PET/CT showed at least one positive lesion in 47% of participants.

28 of 60 participants were positive (95% CI: 33, 60).
18F-FDG PET/CT and bone marrow biopsy were performed as standard of care.

Results

There was no overall difference in disease detection between 89Zr-DFO-daratumumab PET/CT and 18F-FDG PET/CT.

McNemar test gave P = .81.
Detection rates were 43% (26/60) versus 47% (28/60).

Results

89Zr-DFO-daratumumab PET/CT identified myeloma that 18F-FDG PET/CT did not in 13% of participants, with biopsy confirmation of active myeloma.

Myeloma was demonstrated only with 89Zr-DFO-daratumumab PET/CT in eight of 60 participants.
Image-guided biopsy was considered the reference standard for discrepant lesions between the two scans.
Subsequent biopsy confirmed active myeloma in these cases.

Conclusions

The authors conclude CD38-targeted immuno-PET can detect active myeloma in some participants with no signs of disease on 18F-FDG PET/CT.

This supports a complementary role for the tracer relative to FDG PET/CT, given no overall difference in detection rate.
Background notes that current MM imaging is suboptimal, which may limit patient care.

What This Means

This study tested a new type of PET scan for multiple myeloma, a blood cancer that grows in the bone marrow. The scan uses a radioactive tracer attached to daratumumab, a drug that binds to a protein called CD38 found on myeloma cells. It was compared with the standard FDG PET/CT scan in 60 people with myeloma. Overall, the two scans found disease at similar rates: the new scan showed disease in 43% of participants and the standard scan in 47%, with no statistically significant difference. However, in 8 of 60 participants (13%), only the new scan showed myeloma, and later biopsies confirmed active disease in these people. This suggests the CD38-targeted scan may find myeloma that standard FDG imaging misses in some patients. This research suggests the new scan could be a useful addition to existing imaging rather than a replacement, since it did not detect more disease overall. The study was a single phase 2 trial of modest size, so larger studies would be needed to determine how it should be used in patient care.

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Citation

Ulaner G, Kuker R, Diamond B, Hoffman J, Motwani P, Goldenson B, et al.. (2026). Phase 2 Trial of 89Zr-Deferoxamine-Daratumumab for CD38-targeted Immuno-PET/CT Detection of Multiple Myeloma.. Radiology. https://doi.org/10.1148/radiol.260517

Key Findings

What This Means

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