PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma

This study is currently recruiting participants.

Verified by Korean Multiple Myeloma Working Party, April 2006

First Received: April 28, 2006 No Changes Posted

Sponsors and Collaborators:	Korean Multiple Myeloma Working Party Celgene Corporation
Information provided by:	Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:	NCT00319865

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Bortezomib Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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

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

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.

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:

Korean Society of Hematology This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	KMM55
Study First Received:	April 28, 2006
Last Updated:	April 28, 2006
ClinicalTrials.gov Identifier:	NCT00319865 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Korean Multiple Myeloma Working Party:

Multiple Myeloma Relapsed

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Dexamethasone acetate
Immunoproliferative Disorders

Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Protease Inhibitors
Multiple Myeloma
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Thalidomide
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Antibiotics, Antineoplastic
Hemostatic Disorders
Hormones

Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Bortezomib
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 06, 2009