PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00319865|
Recruitment Status : Unknown
Verified April 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was: Recruiting
First Posted : April 27, 2006
Last Update Posted : April 27, 2006
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Velcade Drug: Thalidomide Drug: Adriamycin Drug: Dexamethasone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2005|
|Estimated Study Completion Date :||September 2008|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319865
|Contact: Jae Hoon Lee, M.D.||email@example.com|
|Contact: Hee Keun Kang, R.N.||firstname.lastname@example.org|
|Korea, Republic of|
|Gachon University Gil Hospital||Recruiting|
|Inchon, Korea, Republic of, 405-220|
|Contact: Jae Hoon Lee, M.D. 82-32-460-2186 email@example.com|
|Contact: Hee Keun Kang, R.N. 82-32-460-3655 firstname.lastname@example.org|
|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|