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

NCT00319865 | Unknown Phase 2

• 1 other identifier: KMM55
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma Relapsed

Outcome Measures

Primary Outcomes (1)

• Response rate of PAD induction Therapy

Secondary Outcomes (3)

• 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

Interventions

Velcade DRUG

Thalidomide DRUG

Adriamycin DRUG

Dexamethasone DRUG

Eligibility Criteria

• Age: 0 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Multiple Myeloma Working Party: lead
• Celgene Corporation: collaborator

Study Sites (1)

Gachon University Gil Hospital

Inchon, 405-220, South Korea

RECRUITING

Related Links

• Korean Society of Hematology

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Thalidomide; Doxorubicin; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Jae Hoon Lee, M.D.

  Korean Multiple Myeloma Working Party

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Hoon Lee, M.D.

CONTACT

82-32-460-2186; jhlee@gilhospital.com

Hee Keun Kang, R.N.

CONTACT

82-32-460-3655; happy@gilhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: April 27, 2006
• Study Start: November 1, 2005
• Study Completion: September 1, 2008
• Last Updated: April 27, 2006

Record last verified: 2006-04

Locations

KR (1)