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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263484

Acronym

dtZ

Enrollment

Registered

2005-12-08

Start date

2005-12-31

Completion date

2010-10-31

Last updated

2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Steroids, Fluorinated, Thalidomide, Bisphosphonates

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.

Interventions

DRUGdexamethasone

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.

DRUGthalidomide

100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

DRUGzoledronic acid

4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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 * Severe arrhythmias and cardiac conduction disorders * Liver dysfunction of active viral hepatitis * Osteonecrosis of the jaws (ONJ)

Design outcomes

Primary

Measure	Time frame
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.	4 months

Secondary

Measure	Time frame
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

Countries

India, Singapore, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026