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

NCT ID: NCT00319865

Last Updated: 2006-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-09-30

Brief Summary

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Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Relapsed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Velcade

Intervention Type DRUG

Thalidomide

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Korean Multiple Myeloma Working Party

OTHER

Sponsor Role lead

Principal Investigators

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Jae Hoon Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Korean Multiple Myeloma Working Party

Locations

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Gachon University Gil Hospital

Inchon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Hoon Lee, M.D.

Role: CONTACT

Phone: 82-32-460-2186

Email: [email protected]

Hee Keun Kang, R.N.

Role: CONTACT

Phone: 82-32-460-3655

Email: [email protected]

Facility Contacts

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Jae Hoon Lee, M.D.

Role: primary

Hee Keun Kang, R.N.

Role: backup

Related Links

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http://www.hematology.or.kr/

Korean Society of Hematology

Other Identifiers

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KMM55

Identifier Type: -

Identifier Source: org_study_id