Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma

Authors [No authors listed]
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
Links
INTERVENTION: 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 start of the study to evaluate frailty. Lenalidomide dosage is adjusted according to VES‐13 score and renal function. [VES‐13 score<3] (Fit) CCr>60ml/min Lenalidomide 25mg/body once daily 30 40mg/day weekly [VES‐13 score>=3] (Frail) CCr>60ml/min Lenalidomide 15mg/body once daily 30 20mg/day weekly CONDITION: multiple myeloma PRIMARY OUTCOME: Best response rate SECONDARY OUTCOME: Safety; Incidence of adverse events; Incidence of infection; Progression free survival; Overall survival 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 hav
Epistemonikos ID: 45e803da071202182f493ae212cdb01f209b7ecd
First added on: Aug 23, 2024