PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
Recruitment status was Recruiting
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma|
- Response rate of PAD induction Therapy
- 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
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||September 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319865
|Contact: Jae Hoon Lee, M.D.||firstname.lastname@example.org|
|Contact: Hee Keun Kang, R.N.||email@example.com|
|Korea, Republic of|
|Gachon University Gil Hospital||Recruiting|
|Inchon, Korea, Republic of, 405-220|
|Contact: Jae Hoon Lee, M.D. 82-32-460-2186 firstname.lastname@example.org|
|Contact: Hee Keun Kang, R.N. 82-32-460-3655 email@example.com|
|Principal Investigator: Jae Hoon Lee, M.D.|
|Sub-Investigator: Eun Mi Nam, M.D.|
|Principal Investigator:||Jae Hoon Lee, M.D.||Korean Multiple Myeloma Working Party|