multiple myeloma
Conditions
Interventions
<
Personalized BiRd>
Clarithromycin 200mg x 2/day(Day1-28) p.o Lenalidomide 5-25mg/day(Day1-21) p.o Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o *VES-13(Vulnerable Elders Survey-13) VES-13 is performed before the
3] (Fit) <
Lenalidomide>
CCr>
60ml/min Lenalidomide 25mg/body once daily 30<
CCr<
60ml/min Lenalidomide 15mg/body once daily CCr<
30ml/min Lenalidomide 15mg/body every other day <
Dexamethasone>
40mg/day weekly [VES-13 score>
=3] (Frail) <
60ml/min Lenalidomide 15mg/body once daily 30<
60ml/min Lenalidomide 10mg/body once daily CCr<
30ml/min Lenalidomide 5mg/body once daily <
Sponsors
Yokohama Municipal Citizen's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)aged more than 20 years old (2)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG) (3)relapsed or refractory cases after at least one prior chemotherapy (4)having measurable paraprotein (5)performance status:0-2,or 3 due to osteolytic lesions alone (6)coexisting conditions are eligible as follows: 1)neutrophil count; more than 1,000/mm3 2)platelet count; more than 75,000/mm3 3)serum AST, ALT< 5 times the ULN 4)serum T-Bil< 3 times the ULN 5)serum Cr< 3 times the ULN 6)ejection fraction >= 50% (7)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method (8)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information. (9)patients who are observed RevMate
Exclusion criteria
Exclusion criteria: (1) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more. (2)Patients who have had a complication of active double cancer within the past 5 years. (3)HBs antigen positive,HCV antibody positive, HIV antibody positive patients (4) serious mental disorders such as schizophrenia (5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms (6) Patients with severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection (7)Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome (8)Ptients with thrombosis (9)Women who are or may be pregnant (10)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Incidence of adverse events Incidence of infection Progression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactTomonori Nakazato
Yokohama Municipal Citizen's Hospital Department of Hematology
Outcome results
None listed