Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): a double-blind, randomised controlled trial

Abstract

Background: Prophylactic treatment with bisphosphonates reduces skeletal events in multiple myeloma compared with placebo. However, the toxicity associated with long-term treatment makes it important to find the lowest effective dose. The aim of this study was to compare the effect of two doses of pamidronate on health-related quality of life and skeletal morbidity in patients with newly diagnosed multjple myeloma.Methods: Multiple myeloma patients starting antimyeloma treatment were randomly assigned to monthly infusions of 30 mg (P30) or 90 mg (P90) pamidronate for at least 3 years in a blinded design.Patients were followed every third month for quality of life, skeletal-related events (SRE) and response.Primary outcome was physical function after 12 months assessed by the EORTC QLQ-C30questionnaire. This study is registered with ClinicalTrials.gov, number NCT00376883.

European Myeloma Network Guidelines for the Management of Multiple Myeloma-related Complications

“…20 The major flaw of this study was that it was powered to show differences in quality of life and not in SREs. 20 Finally, the third study, which compared intravenous ZA with oral clodronate, found that ZA reduced the SRE risk compared to clodronate in all patients, irrespective of the presence of lytic lesions at diagnosis, but furthermore, improved overall survival (OS) by ten months in MM patients with lytic lesions at diagnosis. 21,22 These effects continued in patients who received ZA for more than two years.…”

Bones, breasts, and bisphosphonates: rationale for the use of zoledronic acid in advanced and early breast cancer

“…These bisphosphonates have demonstrated varying activity in SRE-prevention trials in patients with multiple myeloma, metastatic breast cancer, prostate cancer, and lung cancer (Table 1). [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] However, it should be noted that pamidronate and ZOL are the only bisphosphonates approved in the metastatic breast cancer setting in the United States. 30,31 Recently, the antiresorptive agent denosumab also gained approval in the United States for the prevention of SREs in patients with bone metastases from solid tumors, including breast cancer.…”

Osteoprotective medication in the era of novel agents: a European perspective on values, risks and future solutions

“…9,10 In the second, two doses of intravenous pamidronate (30 versus 90 mg) showed comparable results regarding time to skeletal-related events and survival time free of such events. 11 The limitation of this study was that it was powered to show differences in quality of life and not in skeletal-related events. 11 The third study compared intravenous (i.v.)…”

“…11 The limitation of this study was that it was powered to show differences in quality of life and not in skeletal-related events. 11 The third study compared intravenous (i.v.) zoledronic acid with oral clodronate and showed that zoledronic acid reduced the risk of skeletalrelated events compared to clodronate in all MM patients, irrespective of the presence of lytic lesions at diagnosis, and improved overall survival by 10 months in patients with lytic lesions at diagnosis.…”