Status:
UNKNOWN
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Korean Multiple Myeloma Working Party
Collaborating Sponsors:
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
Detailed Description
Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
- 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
- known hypersensitivity to thalidomide or dexamethasone
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2008
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00319865
Start Date
November 1 2005
End Date
September 1 2008
Last Update
April 27 2006
Active Locations (1)
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1
Gachon University Gil Hospital
Inchon, South Korea, 405-220