Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
NCT00263484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2011-07-21
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.
Conditions
Interventions
- DRUG
-
20 mg, PO (orally) on days 1-4, 8-11 and 15-18 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
- DRUG
-
thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
- DRUG
-
zoledronic acid
4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Sponsors & Collaborators
-
Singapore General Hospital
collaborator OTHER -
National Cancer Centre, Singapore
collaborator OTHER -
Tan Tock Seng Hospital
collaborator OTHER -
Seoul National University Hospital
collaborator OTHER -
Asan Medical Center
collaborator OTHER -
Samsung Medical Center
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
Christian Medical College, Vellore, India
collaborator OTHER -
Tata Memorial Hospital
collaborator OTHER_GOV -
Gleneagles Hospital
lead OTHER
Principal Investigators
-
Gerrard Teoh, MD · Gleneagles Hospital, Singapore
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-12-31
- Primary Completion
- 2008-10-31
- Completion
- 2010-10-31
Countries
- India
- Singapore
- South Korea
Study Locations
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