Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma (dtZ)
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.
Drug: zoledronic acid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- To assess overall survival (OS) in all patients treated with dtZ regimen. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Assessment of incidence of skeletal related events (SREs). [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Assessment of percent change in renal function in all patients. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: "dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
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.
Other Name: DEXAMETHASONE BEACONSDrug: thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Names: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.
Other Name: ZOMETA
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.
|Christian Medical College|
|Vellore, Tamil Nadu, India, 632004|
|Tata Memorial Hospital|
|Mumbai, India, 400 012|
|Korea, Republic of|
|Chonnam National University Hwasun Hospital|
|Kwangju, Korea, Republic of, 519-809|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|ASAN Medical Center, University of Ulsan, South Korea|
|Seoul, Korea, Republic of, 138-736|
|Samsung Medical Center, Seoul, South Korea|
|Seoul, Korea, Republic of, 135-710|
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|National Cancer Centre, Singapore|
|Singapore, Singapore, 169610|
|Tan Tock Seng Hospital, Singapore|
|Singapore, Singapore, 308433|
|Gleneagles Hospital, Singapore|
|Singapore, Singapore, 258500|
|Study Chair:||Gerrard Teoh, MD||Gleneagles Hospital, Singapore|