Clinical trial · Interventional
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
NCT00263484CI-TRIAL-00005250dtZcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- "dtZ" regimen, Initial therapy
- description
- To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
- interventionNames
- Drug: dexamethasone
- Drug: thalidomide
- Drug: zoledronic acid
Primary outcomes (1)
- measure
- 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
- timeFrame
- 4 months
Secondary outcomes (3)
- measure
- To assess overall survival (OS) in all patients treated with dtZ regimen.
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDYaccoby S, Pearse RN, Johnson CL, Barlogie B, Choi Y, Epstein J. Myeloma interacts with the bone marrow microenvironment to induce osteoclastogenesis and is dependent on osteoclast activity. Br J Haematol. 2002 Feb;116(2):278-90. doi: 10.1046/j.1365-2141.2002.03257.x. PMID 11841428
- BACKGROUNDRosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, Chen BL, Seaman JJ. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003 Oct 15;98(8):1735-44. doi: 10.1002/cncr.11701. PMID 14534891
- BACKGROUNDRajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116. PMID 12409330
- BACKGROUNDWeber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. doi: 10.1200/JCO.2003.03.139. PMID 12506164