NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-152795

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNewly diagnosed multiple myeloma ineligible for hematopoietic stem cell transplantation
Date of first enrollment01/11/2010
Target sample size100
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Thalidomide, Melphalan, Prednisolone INN of the intervention : Thalidomide, Melphalan, Prednisolone Dosage And administration of the intervention : Oral administration Control intervention name : Placebo, Melphalan, Prednisolone INN of the control intervention : Melphalan, Prednisolone Dosage And administration of the control intervention : Oral administration

Outcome(s)

Primary Outcomeresponse rate (CR + PR) based on the EBMT criteria
Secondary Outcome1. Assessment of effectiveness (1)Response rate at each assessment time point (2)Time to response (3)Duration of response 2. Assessment of safety (1)Laboratory test (2)Vital signs, body weight and electrocardiographic test (3)Clinical findings (4)Adverse events

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaKey inclusion criteria 1. Patients with symptomatic multiple myeloma as of IMWG diagnostic criteria 2. Patients with multiple myeloma received no prior treatment with chemical therapeutics. 3. Patients older than 65, or those between 20 and 64 ineligible for hematopoetic stem cell transplantation 4. Serum M-protein >= 500 mg/dL or urinary M-protein excretion >= 200 mg/24h 5. ECOG Performance Status (PS) 0-2 or 3 with osteolytic lesions 6. Patients who have submitted the informed consent to Thalidomide Education and Risk Management System
Exclude criteria1. Patients who have received any thalidomide preparation 2. Patients who have received other drugs for multiple myeloma treatment 3. Patients in pregnancy or lactation 4. Patients who have the medical history of deep vein thrombosis / pulmonary embolism 5. Patients who are positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody 6. White blood cell < 2,000 /mm3, Neutrophil < 1,000 /mm3 or Platelet < 50,000 /mm3 7. Serum creatinine > 3.0 x ULN 8. Serum AST or ALT > 3.0 x ULN 9. Patients under uncontrollable conditions

Related Information

Contact

public contact
Name Fujimoto Pharmaceutical Corporation Department of Clinical Research
Address kaihatsu3@fujimoto-pharm.co.jp
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