multiple myeloma
Conditions
Interventions
<
ClaPD>
Clarithromycin 400mg x 2/day(Day1-28) p.o Pomalidomide 1-4mg/day(Day1-21) p.o Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o 28day/cycle until PD
Sponsors
Tokai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)aged 20 and more than 20 years old ,and 80 and less than 80 years old (2)progression disease cases after latest chemotherapy who received bortezomib and lenalidomide before. (3)having measurable paraprotein; M protein>=0.5g/dL (IgG,IgA,IgM),or M protein>=0.05g/dL (IgD), or Urine M protein>200mg/day (4)performance status:0-2,or 3 due to osteolytic lesions alone (5)coexisting conditions are eligible as follows: ?serum AST, ALT< 3 times the ULN ?neutrophil count; more than 1,000/mm3 ?platelet count; more than 75,000/mm3 ?serum AST, ALT< 5 times the ULN ?percutaneous oxygen saturation>=93% (6)expected surviving more than 1 month (7)patients who are observed RevMate (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
Exclusion criteria
Exclusion criteria: Pregnancy or Lactation Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 3 or more Patients with severe hepatic dysfunction, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, and uncontrolled hypertension Patients with tuberculosis, herpetic keratoconjunctivitis, systemic fungal infection, and with other active infections Patients with acute myocardial infarction within 6 months, with deep venous thrombosis or with pulmonary embolism within 3 years Patients who have had a complication of active double cancer within the past 5 years HBs antigen positive,HCV antibody positive, HIV antibody positive patients Patients with a clinical picture of interstitial pneumonia or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival,Overall survival,Complete response rate,Stringent complete response rate,Very good partial response rate,Partial response rate, | — |
Countries
Japan
Contacts
Public ContactHiroki Numata
Tokai University Division of Hematology/Oncology
Outcome results
None listed