Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gleneagles Hospital
• Collaborators: Asan Medical Center; Chonnam National University Hospital; Christian Medical College, Vellore, India; National Cancer Centre, Singapore; Samsung Medical Center; Seoul National University Hospital; Singapore General Hospital; Tan Tock Seng Hospital; Tata Memorial Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphosphonates; Thalidomide; Zoledronic Acid

Criteria

Inclusion Criteria:

• Age at or above 21 years

• Clinical diagnosis of MM

• Active MM with measurable disease

• Signed written informed consent

• Signed consent for drug safety program for thalidomide

Exclusion Criteria:

• Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS)

• Patients with Indolent MM (IMM), or Smouldering MM (SMM)

• Known hypersensitivity (including severe cutaneous reactions) to d, t or Z

• Fulminant sepsis

• Females in the reproductive age group who refuse contraception

• Pregnancy

• 24 hr urinary creatinine clearance time (CCT) <30 ml/min

• Previous renal transplantation

• Severe peripheral neuropathy

• Recurrent DVT or PE

• Severe arrhythmias and cardiac conduction disorders

• Liver dysfunction of active viral hepatitis

• Osteonecrosis of the jaws (ONJ)