PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00319865
- Lead Sponsor
- Korean Multiple Myeloma Working Party
- 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 relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.
We desined prospective multicenter phase 2 study using these combination sequentially.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 47
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate of PAD induction Therapy
- Secondary Outcome Measures
Name Time Method Response rate of PAD followed by Thal/Dex maintenance Progression free survival and Overall survival of PAD/Thal-Dex. To evaluate toxicities of PAD/Thal-Dex
Trial Locations
- Locations (1)
Gachon University Gil Hospital
🇰🇷Inchon, Korea, Republic of