Multiple Myeloma
Conditions
Interventions
Test Group:oral domestic produced lenalidomide capsule
Control:oral domestic produced lenalidomide capsule
Sponsors
West China Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria:? Men or postmenopausal women, aged 18 to 70 years old;? BMI=Body weight(kg)/Height2(m2),between 18 and 26;? ECOG performance status 60ml/min,AST, ALT = 80g/L,Absolute neutrophil count >*1.5*10 9/L,Platelets >= 80*10 9/L.Note:Ccr=(140-Age)×Body weight(kg)/[72×Scr(mg/dl)]?Ccr=[(140-Age)×Body weight(kg)]/[0.818×Scr(umol/L)]; Women by the results×0.85.? No smoking, no alcohol, and agreed to during the test ban smoking drinkers;? No parenting plan;? Aware of the potential teratogenic risk of drug, haematological toxicity (neutropenia and thrombocytopenia), caused by deep vein thrombosis and pulmonary embolism;? Not donate blood during the medication, wash-out period and after disabling the studied drug for at least 28 days;? Do not break, chew, or open the lenalidomide capsules;? In addition,for male subjects: have sex with the Women of childbearing potential to use condom during the medication, wash-out period and after disabling the studied drug for at least 28 days (it is no exception even if she have done vasectomy);? study entry and for the duration of study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: ? Any serious medical condition,laboratory abnormalities or mental illness can not participate this test; ? Pregnant or nursing; ? Any case of laboratory abnormalities,any risk for subjects and or will confuse the interpretation of the data; ? have significant heart disease activity within the previous 12 months; the angina have to be treated,have a history of poorly controlled hypertension (systolic blood pressure> 160, diastolic> 90mmHg); MI; class II-IV congestive heart failure according to New York Heart Association; Unstable angina. ? History of malignancy in addition to multiple myeloma, unless the patient has been cured cancer disease = 3 years,except for the following tumor diseases: Basal cell skin cancer; Cervical carcinoma in situ; Breast carcinoma in situ; Squamous cell carcinoma of the skin; ? Incidental histologic findings of prostate cancer (TNM staging of T1a or T1b); ? have history of drug allergy, allergic disease or allergic constitution; ? = 2 peripheral neuropathy (see Annex score 4.FACT/GOG-NTX); ? with DVT or PE within the previous 12 months; ? the patients have digestive diseases to drug absorption; ? the patients have urinary tract obstruction or difficulty urinating; ? the patient hypovolemia; ? subjects with HBsAg-positive,syphilis-positive, hepatitis C antibody-positive or HIV antibody-positive; ? participate any other drug test within the last 3 months; ? There is evidence to suggest drug abusers.
Countries
China
Contacts
Public ContactShen Qi
Outcome results
None listed