title: Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group.
abstract: 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.
authors.affiliation: West Los Angeles Veterans Affairs Medical Center, CA 90073, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Berenson
authors.forename: A
authors.initials: A
authors.lastname: Lichtenstein
authors.forename: L
authors.initials: L
authors.lastname: Porter
authors.forename: M A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: R
authors.initials: R
authors.lastname: Bordoni
authors.forename: S
authors.initials: S
authors.lastname: George
authors.forename: A
authors.initials: A
authors.lastname: Lipton
authors.forename: A
authors.initials: A
authors.lastname: Keller
authors.forename: O
authors.initials: O
authors.lastname: Ballester
authors.forename: M J
authors.initials: MJ
authors.lastname: Kovacs
authors.forename: H A
authors.initials: HA
authors.lastname: Blacklock
authors.forename: R
authors.initials: R
authors.lastname: Bell
authors.forename: J
authors.initials: J
authors.lastname: Simeone
authors.forename: D J
authors.initials: DJ
authors.lastname: Reitsma
authors.forename: M
authors.initials: M
authors.lastname: Heffernan
authors.forename: J
authors.initials: J
authors.lastname: Seaman
authors.forename: R D
authors.initials: RD
authors.lastname: Knight
mesh_terms: D000368:Aged; D004164:Diphosphonates / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D006934:Hypercalcemia / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D010014:Osteolysis / Q000188:drug therapy* / Q000209:etiology; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D000077268:Pamidronate; D013117:Spinal Cord Compression / Q000209:etiology / Q000517:prevention & control; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; D000077268:Pamidronate