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Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study
J R Berenson1, A Lichtenstein, L Porter
1West Los Angeles Veterans Affairs Medical Center, CA 90073, USA.
Background:
Skeletal complications are a major clinical manifestation of multiple myeloma. These complications are caused by soluble factors that stimulate osteoclasts to resorb bone. Bisphosphonates such as pamidronate inhibit osteoclastic activity and reduce bone resorption.
Methods:
Patients with stage III multiple myeloma and at least one lytic lesion received either placebo or pamidronate (90 mg) as a four-hour intravenous infusion given every four weeks for nine cycles in addition to antimyeloma therapy. The patients were stratified according to whether they were receiving first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy at entry into the study. Skeletal events (pathologic fracture, irradiation of or surgery on bone, and spinal cord compression), hypercalcemia (symptoms or a serum calcium concentration > or = 12 mg per deciliter [3.0 mmol per liter]), bone pain, analgesic-drug use, performance status, and quality of life were assessed monthly.
Results:
Among 392 treated patients, the efficacy of treatment could be evaluated in 196 who received pamidronate and 181 who received placebo. The proportion of patients who had any skeletal events was significantly lower in the pamidronate group (24 percent) than in the placebo group (41 percent, P < 0.001), and the reduction was evident in both stratum 1 (P = 0.04) and stratum 2 (P = 0.004). The patients who received pamidronate had significant decreases in bone pain and no deterioration in performance status and quality of life. Pamidronate was tolerated well.
Conclusions:
Monthly infusions of pamidronate provide significant protection against skeletal complications and improve the quality of life of patients with stage III multiple myeloma.
Insights
Pamidronate significantly reduces skeletal complications in multiple myeloma patients. This bisphosphonate treatment also improves quality of life and reduces bone pain, offering a well-tolerated option for managing bone disease.
Area of Science:
- Oncology
- Pharmacology
- Bone Biology
Background:
- Skeletal complications are a primary clinical issue in multiple myeloma, driven by factors that increase osteoclast activity and bone resorption.
- Bisphosphonates, like pamidronate, are utilized to inhibit osteoclasts and mitigate bone loss.
Purpose of the Study:
- To evaluate the efficacy of pamidronate in preventing skeletal events in patients with stage III multiple myeloma.
- To assess the impact of pamidronate on bone pain, performance status, and quality of life.
Main Methods:
- A randomized controlled trial involving 392 patients with stage III multiple myeloma and lytic lesions.
- Patients received either pamidronate (90 mg IV infusion every four weeks for nine cycles) or placebo, alongside standard antimyeloma therapy.
- Outcomes including skeletal events, hypercalcemia, bone pain, and quality of life were monitored monthly.
Main Results:
- Pamidronate significantly reduced the incidence of skeletal events compared to placebo (24% vs. 41%, P < 0.001).
- This protective effect was observed in both first-line and second-line chemotherapy groups.
- Patients receiving pamidronate experienced decreased bone pain without compromising performance status or quality of life.
Conclusions:
- Monthly pamidronate infusions are effective in protecting against skeletal complications in stage III multiple myeloma.
- Pamidronate treatment improves the quality of life for patients with multiple myeloma and associated bone disease.