Status:
UNKNOWN
TCD Followed by autoSCT for Newly Diagnosed MM Patients
Lead Sponsor:
Korean Multiple Myeloma Working Party
Collaborating Sponsors:
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed by high dose chem...
Detailed Description
Phase II clinical trial for the patients with newly diagnosed. TCD (thalidomide, cyclophosphamide and dexamethasone) will be applied for the patients as an induction chemotherapy, followed by high dos...
Eligibility Criteria
Inclusion
- Newly diagnosed multiple myeloma in aged between 18 and 75 years old with following mesurable leisons: (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day) -
Exclusion
- \- 1. Smoldering or indolent myeloma 2. ECOG performance status \> 3 point 3. Known hypersensitivity to cyclphosphamide, thalidomide or dexamethasone 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 5. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg 6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal) 7. Creatinine cliearance \< 20 ml/min 8. Corrected serum calcium ≥ 14 mg/dL 9. Sepsis or current active infection 10. Pregnancy or breast feeding 11. Uncontrolled Diabetes Mellitus 12. Previous history of Recurrent DVT or pulmonary embolism 13. Active ulcers detected by gastroscopy 14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- 15\. Receipt of extensive radiation therapy within 4 weeks
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00349115
Start Date
June 1 2006
End Date
June 1 2008
Last Update
May 6 2008
Active Locations (1)
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1
Je-Jung Lee
Hwsun-eup, Hwasun-gun, Jeollanam-do, South Korea, 519-809