Back to resultsPAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Velcade
Thalidomide
Adriamycin
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma Relapsed
Eligibility 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 </= 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
Sites / Locations
- Gachon University Gil HospitalRecruiting
Outcomes
Primary Outcome Measures
Response rate of PAD induction Therapy
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00319865
First Posted
April 28, 2006
Last Updated
April 28, 2006
Sponsor
Korean Multiple Myeloma Working Party
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00319865
Brief Title
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
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 Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Multiple Myeloma Working Party
Collaborators
Celgene Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma Relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Velcade
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Response rate of PAD induction Therapy
Secondary Outcome Measure Information:
Title
Response rate of PAD followed by Thal/Dex maintenance
Title
Progression free survival and Overall survival of PAD/Thal-Dex.
Title
To evaluate toxicities of PAD/Thal-Dex
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 </= 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hoon Lee, M.D.
Phone
82-32-460-2186
Email
jhlee@gilhospital.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Keun Kang, R.N.
Phone
82-32-460-3655
Email
happy@gilhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D.
Organizational Affiliation
Korean Multiple Myeloma Working Party
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Inchon
ZIP/Postal Code
405-220
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D.
Phone
82-32-460-2186
Email
jhlee@gilhoospital.com
First Name & Middle Initial & Last Name & Degree
Hee Keun Kang, R.N.
Phone
82-32-460-3655
Email
happy@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D.
First Name & Middle Initial & Last Name & Degree
Eun Mi Nam, M.D.
12. IPD Sharing Statement
Links:
URL
http://www.hematology.or.kr/
Description
Korean Society of Hematology
Learn more about this trial
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
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