Proteasome inhibitor and immunomodulatory drug pre-treated relapsed and/or refractory multiple myeloma after two or more prior lines of chemotherapy
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. Phase1 level -1 bortzomib 1.0 mg/m2, le
Sponsors
Nagoya City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diagnosed as having symptomatic multiple myeloma before initial treatment 2) relapsed and or refractory cases after at least two prior chemotherapy including both proteasome inhibitor and one immunomodulatory drug 3) no limit of age 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) at least 14 days have passed after the prior therapy of multiple myloma, including chemotherapy, radiotherapy, and surgery. Transient administration of steroid is permitted 9) absolute neutrophil count no less than 750/mm3, platelet count no less than 50,000/mm3, , AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearrance 50 mL/min or above at phase 1 study (no limitation at the phase 2 study except for need of dialysis), SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction at least 50% 10) no history of hypersensitivity to bortezomib, lenalidomide, and dexamethasone 11) peripheral neuropathy(PN) within grade 2 without pain. Management of PN is permitted. 12) 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 |
|---|---|
| maximum tolerated dose objective response rate, PR above | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival progression-free survival time to progression adverse event treatment efficacy according to the translocation of chromosome myeloma related | — |
Countries
Japan
Contacts
Public ContactHaruhito Totani
Nagoya City University Hospital Division of Hematology & Collagen Diseases
Outcome results
None listed