PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
NCT ID: NCT00319865
Last Updated: 2006-04-27
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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UNKNOWN
PHASE2
47 participants
INTERVENTIONAL
2005-11-30
2008-09-30
Brief Summary
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Detailed Description
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We desined prospective multicenter phase 2 study using these combination sequentially.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Velcade
Thalidomide
Adriamycin
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day
* Age \< 75
* Performance status \</= ECOG 2
* Expected survival \> 6 months
* who signs the informed consent
Exclusion Criteria
* known refractoriness to thalidomide + dexamethasone
* Previous Velcade therapy
* Sepsis
* Woman in reproductive age
* Serum creatinine \> 2 mg/dL ; 24 hour creatinine clearance \< 30 ml/min; past medical history of kidney transplatation
* Peripheral neuropathy \>/= grade 2
* Recurrent DVT or pulmonary embolism
* Cardiac ejection fraction \<0.5 : Severe conduction disorder
* Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
* Active ulcers in gastrofiberscope
0 Years
75 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Korean Multiple Myeloma Working Party
OTHER
Principal Investigators
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Jae Hoon Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korean Multiple Myeloma Working Party
Locations
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Gachon University Gil Hospital
Inchon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jae Hoon Lee, M.D.
Role: primary
Hee Keun Kang, R.N.
Role: backup
Related Links
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Korean Society of Hematology
Other Identifiers
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KMM55
Identifier Type: -
Identifier Source: org_study_id