Status:
COMPLETED
Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
Lead Sponsor:
Gleneagles Hospital
Collaborating Sponsors:
Singapore General Hospital
National Cancer Centre, Singapore
Conditions:
Multiple Myeloma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 new...
Detailed Description
Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is associated with si...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00263484
Start Date
December 1 2005
End Date
October 1 2010
Last Update
July 21 2011
Active Locations (10)
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1
Tata Memorial Hospital
Mumbai, Mumbai, India, 400 012
2
Christian Medical College
Vellore, Tamil Nadu, India, 632004
3
Singapore General Hospital
Singapore, Singapore, 169608
4
National Cancer Centre, Singapore
Singapore, Singapore, 169610