NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180048

Registered date:19/02/2019

1601 study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedMultiple myeloma
Date of first enrollment13/05/2016
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Bortezomib (subcutaneous injection, days 1,8) plus lenalidomide (days 1-14) dexamethasone (20mg/day, days 1,2,8,9) were administered for eight 21-cycles. Dose of lenalidomide is adjusted according to the degree of renal failure. Twelve cycle of Ld therapy is conducted following to the BLd therapy.

Outcome(s)

Primary Outcomeobjective response rate, very good PR (VGPR) above
Secondary OutcomeCR rate overall response (PR above) overall survival progression-free survival adverse event treatment efficacy according to the translocation of chromosome myeloma related

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Diagnosed as having symptomatic multiple myeloma 2) 65 years of age or more, under 80 3) Transplant in-eligible patients with 20 years or more and under 64 years. 4) Either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy. Females of childbearing potential must adhere to the guideline of the Revmate program. 5) Men who agreed to use contraception according to the guideline of the Revmate program. 6) ECOG performance status 0-2,or 3 due to osteolytic lesions alone 7) Having a measurable para-protein defined as serum monoclonal immunoglobulin concentration of at least 1.0g/dL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of para-protein per 24 hours in spite of the type of myeloma. Measurable lesion of plasmacytoma, above diameter 5 cm, detected by CT scan. 8) No history of myeloma treatment. Transient administration of steroid is permitted 9) Absolute neutrophil count no less than 1000/mm3, platelet count no less than 75,000/mm3, , AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearance 30 mL/min or above SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia requiring medical intervention, cardiac ejection fraction at least 50% 10) Peripheral neuropathy (PN) within grade 2 without pain. Management of PN is permitted. 11) written informed consent by the patient
Exclude criteria1) synchronous or metachronous malignancy 2) active infection or history of tuberculosis 3) severe constipation or ileus 4) interstitial pneumonia, pulmonary fibrosis 5) uncontrolled diabetes 6) inability to intake antithrombotic medication 7) pregnant or nursing women mellitus 8) uncontrollable hypertension 9) psychological disturbance 10) active double cancer 11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive 12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia 13) glaucoma 14) primary plasma cell leukemia 15) no administration of blood transfusion or G-CSF within 7days before the treatment 16) no evidence of cardiac or intestinal amyloidosis 17) allergic history to borate or mannitol 18) Inappropriate case of the enrollment to this study judged by the attending physician

Related Information

Contact

Public contact
Name MASAKI RI
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan Aichi Japan 467-8601
Telephone +81-52-853-8738
E-mail rrmasaki@med.nagoya-cu.ac.jp
Affiliation Nagoya city university hospital
Scientific contact
Name MASAKI RI
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan Aichi Japan 467-8601
Telephone +81-52-853-8738
E-mail rrmasaki@med.nagoya-cu.ac.jp
Affiliation Nagoya city university hospital