drugset / Trial / NCT00263484
Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
Phase 2
Completed
56 enrolled
Gleneagles Hospital
Asan Medical Center · collabChonnam National University Hospital · collabChristian Medical College, Vellore, India · collabNational Cancer Centre, Singapore · collabSamsung Medical Center · collabSeoul National University Hospital · collabSingapore General Hospital · collabTan Tock Seng Hospital · collabTata Memorial Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2008-10
- Completion
- 2010-10
Publications
- Background Yaccoby S, Pearse RN, Johnson CL, Barlogie B, Choi Y, Epstein J. Myeloma interacts with the bone marrow microenvironment to induce osteoclastogenesis and is dependent on osteoclast activity. Br J Haematol. 2002 Feb;116(2):278-90. doi: 10.1046/j.1365-2141.2002.03257.x.
- Background Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, Chen BL, Seaman JJ. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003 Oct 15;98(8):1735-44. doi: 10.1002/cncr.11701.
- Background Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116.
- Background Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. doi: 10.1200/JCO.2003.03.139.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 100 mg | Oral |
| Subject | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |