JRCT ID: jRCTs031180335
Registered date:18/03/2019
PIANO study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | multiple myeloma |
Date of first enrollment | 18/03/2019 |
Target sample size | 64 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | CR rate at day 100 from autologous transplantation |
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Secondary Outcome | 1) 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 |
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Age maximum | <= 70age old |
Gender | Both |
Include criteria | 1) 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 criteria | 1) 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
Primary Sponsor | Kanda Yoshinobu |
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Secondary Sponsor | |
Source(s) of Monetary Support | Bristol Myers Squibb (former Celgene),Bristol Myers Squibb (former Celgene) |
Secondary ID(s) | UMIN000012465 |
Contact
Public contact | |
Name | Yoshinobu Kanda |
Address | 1-847 Amanumacho, Omiyaku, Saitama-city, Saitama Saitama Japan 330-8503 |
Telephone | +81-48-647-2111 |
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 |
ycanda-tky@umin.ac.jp | |
Affiliation | Saitama Medical Center, Jichi Medical University |