PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Detailed Description
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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.

Official Title
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PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Velcade
* Drug: Thalidomide
* Drug: Adriamycin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Velcade|nan|
|Drug: Thalidomide|nan|
|Drug: Adriamycin|nan|
|Drug: Dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of PAD induction Therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma Relapsed