Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
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
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
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.
Study Started
Dec 31
Primary Completion
Oct 31
Study Completion
Oct 31
Last Update
Jul 21

Drug dexamethasone

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.

  • Other names: ZOMETA

"dtZ" regimen, Initial therapy Experimental

To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.


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
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)
No Results Posted