PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma Relapsed
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Velcade Type: Drug
Name: Thalidomide Type: Drug
Name: Adriamycin Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: N/A
Gender: Both
Criteria: 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
- 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
Location
Gachon University Gil Hospital
Inchon, Korea, Republic of
Status: Recruiting
Contact: Jae Hoon Lee, M.D. - 82-32-460-2186 - jhlee@gilhoospital.com
Start Date
November 2005
Completion Date
September 2008
Sponsors
Korean Multiple Myeloma Working Party
Source
Korean Multiple Myeloma Working Party
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page