Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT00263484
- Lead Sponsor
- Gleneagles Hospital
- 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 newly-diagnosed multiple myeloma.
- 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 significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. Hence, for safety reasons, patients frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose) dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher (three-weekly) dosing frequency.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description "dtZ" regimen, Initial therapy dexamethasone To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma. "dtZ" regimen, Initial therapy thalidomide To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma. "dtZ" regimen, Initial therapy zoledronic acid To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
- Primary Outcome Measures
Name Time Method 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen. 4 months
- Secondary Outcome Measures
Name Time Method To assess overall survival (OS) in all patients treated with dtZ regimen. 4 months Assessment of incidence of skeletal related events (SREs). 4 months Assessment of percent change in renal function in all patients. 4 months
Trial Locations
- Locations (10)
Christian Medical College
🇮🇳Vellore, Tamil Nadu, India
Tata Memorial Hospital
🇮🇳Mumbai, India
Chonnam National University Hwasun Hospital
🇰🇷Kwangju, Korea, Republic of
Samsung Medical Center, Seoul, South Korea
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
ASAN Medical Center, University of Ulsan, South Korea
🇰🇷Seoul, Korea, Republic of
National Cancer Centre, Singapore
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital, Singapore
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
Gleneagles Hospital, Singapore
🇸🇬Singapore, Singapore