An International, Multicenter, Non-Randomized, Open-Labeled Study to Evaluate the Efficacy of Lower Dose Dexamethasone/Thalidomide and Higher Frequency ZOMETA(TM) in the Treatment of Previously Untreated Patients With Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- dexamethasone
- Conditions
- Multiple Myeloma
- Sponsor
- Gleneagles Hospital
- Enrollment
- 56
- Locations
- 10
- Primary Endpoint
- 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
"dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
Intervention: dexamethasone
"dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
Intervention: thalidomide
"dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
Intervention: zoledronic acid
Outcomes
Primary Outcomes
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
Time Frame: 4 months
Secondary Outcomes
- 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)