Multiple Myeloma Clinical Trial
— dtZOfficial 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
Verified date | July 2011 |
Source | Gleneagles Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | October 2010 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Hospital | Mumbai | |
India | Christian Medical College | Vellore | Tamil Nadu |
Korea, Republic of | Chonnam National University Hwasun Hospital | Kwangju | |
Korea, Republic of | ASAN Medical Center, University of Ulsan, South Korea | Seoul | |
Korea, Republic of | Samsung Medical Center, Seoul, South Korea | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Singapore | Gleneagles Hospital, Singapore | Singapore | |
Singapore | National Cancer Centre, Singapore | Singapore | |
Singapore | Singapore General Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital, Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
Gleneagles Hospital | Asan Medical Center, Chonnam National University Hospital, Christian Medical College, Vellore, India, National Cancer Centre, Singapore, Samsung Medical Center, Seoul National University Hospital, Singapore General Hospital, Tan Tock Seng Hospital, Tata Memorial Hospital |
India, Korea, Republic of, Singapore,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen. | 4 months | No | |
Secondary | To assess overall survival (OS) in all patients treated with dtZ regimen. | 4 months | No | |
Secondary | Assessment of incidence of skeletal related events (SREs). | 4 months | No | |
Secondary | Assessment of percent change in renal function in all patients. | 4 months | Yes |
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