NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180335

Registered date:18/03/2019

PIANO study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedmultiple myeloma
Date of first enrollment18/03/2019
Target sample size64
Countries of recruitment
Study typeInterventional
Intervention(s)1) 4 courses of CyBorD therapy(cyclophosphamide, bortezomib, and dexamethasone) 2) If not reached VGPR by CyBorD therapy, add lenalidomide and dexamethasone therapy, maximum 4 courses 3) Periheral blood stem cell harvest mobilised by filgrastim alone or cyclophosphamide and filgrastim 4) High dose therapy of melphalan followed by autologous periheral blood stem cell transplantation 5) Maintenance therapy with lenalidomide for 2 years or till PD

Outcome(s)

Primary OutcomeCR rate at day 100 from autologous transplantation
Secondary Outcome1) overall response rate 2) treatment completion rate 3) 3-year progression free survival 4) 3-year overall survival 5) safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
GenderBoth
Include criteria1) Patients diagnosed with symptomatic multiple myeloma 2) Patients who have never received therapy for myeloma, excluding local radiation therapy 3) Patients with measurable disease (Serum M-protein >= 1g/dL, Urinary M-protein >=200mg/day, or tumor derived-FLC(iFLC)>100mg/L) 4) Performance Status being 0-2. Patients with Performance Status of 3 due to bone lesion are permitted 5) Patients who have the following laboratory values within 14 days before enrollment 1. SpO2 >= 94% 2. neutrophil count >= 1000/mm3 3. platelet count >= 75000/mm3 4. Patients who do not require hemodialysis 5. serum total bilirubin <= 1.5 x upper limit of normal 6. ALT <= 2.5 x upper limit of normal 7. AST <= 2.5 x upper limit of normal 7) Patients who agreed to contraception by an appropriate method 8) Written informed concent has been obtained
Exclude criteria1) Patients with a history of allergy to the drugs used in the protocol therapy 2) Patients who can not be expected to survive more than 3 months 3) Patients who suffered another carcinoma within 5 years 4) Patients with HBs antigen-positive, or HCV antibody-positive, or HIV antibody-positive 5) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more. 6) Patients with serious active infection or patients who are suspected to have serious active infection infections 7) Patients with serious mental disorders 8) Patients with serious pulmonary dysfunction 9) Patients with interstitial pneumonia or pulmonary fibrosis 10) Patients with serious heart dysfunction 11) Patients with poorly controlled diabetes 12) Patients receiving hemodialysis 13) Patient who are or may be pregnant or are nursing 14) Patients who are determined to be inappropriate for study by physician

Related Information

Contact

Public contact
Name Yoshinobu Kanda
Address 1-847 Amanumacho, Omiyaku, Saitama-city, Saitama Saitama Japan 330-8503
Telephone +81-48-647-2111
E-mail ycanda-tky@umin.ac.jp
Affiliation Saitama Medical Center, Jichi Medical University
Scientific contact
Name Yoshinobu Kanda
Address 1-847 Amanumacho, Omiyaku, Saitama-city, Saitama Saitama Japan 330-8503
Telephone +81-48-647-2111
E-mail ycanda-tky@umin.ac.jp
Affiliation Saitama Medical Center, Jichi Medical University