PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Korean Multiple Myeloma Working Party
Collaborator:
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:
NCT00319865
First received: April 28, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Velcade Drug: Thalidomide Drug: Adriamycin Drug: Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Doxorubicin
Doxorubicin hydrochloride
Bortezomib
U.S. FDA Resources
Further study details as provided by Korean Multiple Myeloma Working Party:
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
| Estimated Enrollment: | 47 |
| 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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319865
Contacts
| Contact: Jae Hoon Lee, M.D. | 82-32-460-2186 | jhlee@gilhospital.com |
| Contact: Hee Keun Kang, R.N. | 82-32-460-3655 | happy@gilhospital.com |
Locations
| Korea, Republic of | |
| Gachon University Gil Hospital | Recruiting |
| Inchon, Korea, Republic of, 405-220 | |
| Contact: Jae Hoon Lee, M.D. 82-32-460-2186 jhlee@gilhoospital.com | |
| Contact: Hee Keun Kang, R.N. 82-32-460-3655 happy@gilhospital.com | |
| Principal Investigator: Jae Hoon Lee, M.D. | |
| Sub-Investigator: Eun Mi Nam, M.D. | |
Sponsors and Collaborators
Korean Multiple Myeloma Working Party
Celgene Corporation
Investigators
| Principal Investigator: | Jae Hoon Lee, M.D. | Korean Multiple Myeloma Working Party |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00319865 History of Changes |
| Other Study ID Numbers: | KMM55 |
| Study First Received: | April 28, 2006 |
| Last Updated: | April 28, 2006 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Korean Multiple Myeloma Working Party:
|
Multiple Myeloma Relapsed |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib Doxorubicin Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013