KEY TAKEAWAYS
- This study analyzed whether extended ZOL treatment is better for optimal protection of progressive bone disease in MM patients.
- The study demonstrated that extended four-year monthly Zoledronic acid treatment offered superior protection against progressive bone disease in MM compared to a two-year regimen.
The study included newly diagnosed symptomatic Multiple Myeloma (MM) patients. They were enrolled and underwent 2 years of Zoledronic Acid (ZOL) treatment before being randomized into two groups. One group received an additional 2 years of monthly intravenous ZOL, while the other group was only observed. Patients (pts) who showed signs of Progressive Bone Disease (PBD) just before the randomization phase were not included but continued to receive ZOL.
All pts were monitored through monthly clinical visits, blood sample collections, biannual low-dose whole-body CT scans, and quarterly quality-of-life questionnaires. Additionally, bone imaging was carried out when deemed medically necessary. PBD criteria included a minimum of 25% growth in existing osteolytic lesions or new ones (at least 10 mm in increase/diameter), new fractures, or lesions requiring radiation therapy or surgery.
The study randomized 192 MM pts. The median follow-up period was 21.6 months post-randomization. A total of 8 cases of PBD occurred in the ZOL group vs. 18 in the observational arm. The ZOL arm showed a lower PBD risk. The incidence of Bisphosphonate Osteonecrosis of the Jaw (BON) after two years was 3.6%. Moreover, the two groups had no difference in overall survival.
The four years ZOL treatment proved superior to two years in protection against PBD in MM.
Source: https://imsannual2023.eventscribe.net/fsPopup.asp?PresentationID=1302374&mode=presInfo
Lund, T. Four years treatment with Zoledronic Acid is superior to two years in protection against progressive bone disease in Multiple Myeloma.