Elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Conditions
Interventions
bortezomib (subcutaneous injection, days 1,8) plus lenalidomode (days 1-14) dexamethasone (20mg/day, days 1,2,8,9) were administered for eight 21-cycles. bortzomib 1.3 mg/m2, lenalidomide 25mg/b
Sponsors
Nagoya City University Hospital Division of Hematology & Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diagnosed as having symptomatic multiple myeloma 2) 65 years of age or more, under 80 3) transplant in-eligble 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) performance status 0-2,or 3 due to osteolytic lesions alone 7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0gdL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma 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 clearrance 30 mL/min or above SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia reqiuring 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
Exclusion criteria
Exclusion criteria: 1) synchronous or metachronous malignancy 2) active infection 3) severe constipation or illeus 4) interstitial pneoumonia, 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 adminstration of blood transfusion or G-CSF within 7days befor the treatment 16) no evidence of cardiac or intestinal amyloidosis 17) allergic history to borate or mannitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, very good PR (VGPR) above | — |
Secondary
| Measure | Time frame |
|---|---|
| CR rate overall response (PR above) overall survival progression-free survival adverse event treatment efficacy according to the translocation of chromosome myeloma related | — |
Countries
Japan
Contacts
Public ContactMasaki RI
Nagoya City University Hospital Division of Hematology & Oncology
Outcome results
None listed