Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
NCT ID: NCT00263484
Last Updated: 2011-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2005-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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"dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
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.
thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
zoledronic acid
4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Interventions
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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.
thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
21 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
National Cancer Centre, Singapore
OTHER
Tan Tock Seng Hospital
OTHER
Seoul National University Hospital
OTHER
Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Chonnam National University Hospital
OTHER
Christian Medical College, Vellore, India
OTHER
Tata Memorial Hospital
OTHER_GOV
Gleneagles Hospital
OTHER
Responsible Party
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Gleneagles Hospital, Singapore
Principal Investigators
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Gerrard Teoh, MD
Role: STUDY_CHAIR
Gleneagles Hospital, Singapore
Locations
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Tata Memorial Hospital
Mumbai, Mumbai, India
Christian Medical College
Vellore, Tamil Nadu, India
Singapore General Hospital
Singapore, , Singapore
National Cancer Centre, Singapore
Singapore, , Singapore
Gleneagles Hospital, Singapore
Singapore, , Singapore
Tan Tock Seng Hospital, Singapore
Singapore, , Singapore
Chonnam National University Hwasun Hospital
Gwangju, Gwangju, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Samsung Medical Center, Seoul, South Korea
Seoul, Seoul, South Korea
ASAN Medical Center, University of Ulsan, South Korea
Seoul, Seoul, South Korea
Countries
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References
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Yaccoby 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.
Rosen 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.
Rajkumar 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.
Weber 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.
Related Links
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Clinic for Blood Disorders and Research (CBD), Gleneagles Hospital, Singapore
Other Identifiers
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SQMM01(dtZ)
Identifier Type: -
Identifier Source: org_study_id
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