There is a randomized study in North America and Europe respectively about the effective data summarizes for the relapse/refractory multiple myeloma patients in the MM-009 and MM-010 study, which can assess the efficacy and safety of this product. In the two-international multicenter, double-blind, placebo-controlled studies, the multiple myeloma patients who have received at least one treatment for myeloma before are the research subjects, the researchers compare the treatment lenalidomide (CAS:191732-72-6)
+ oral pulse high dose dexamethasone with dexamethasone monotherapy treatment. In these two studies, there are following requirements: the total number of neutrophils (ANC) ≥ 1000/mm3, the platelet count ≥ 75,000/mm3, serum creatinine ≤ 2.5 mg/dL, serum SGOT/AST or SGPT/ALT ≤ 3.0 times than the normal value, and serum direct bilirubin ≤ 2.0mg /dL.
In the both studies, the patients in the lenalidomide (CAS:191732-72-6)
/ dexamethasone group are asked to take 25mg lenalidomide (CAS: 191732-72-6)
per os during 1 – 21 days in every 28-day-cycle. Whereas they are asked to take the matching placebo capsule once a day during 22 – 28 days. The patients in the placebo/dexamethasone group are asked to take the placebo capsule per os one pill per day during 1 – 28 days in every 28-day-cycle. The patients in both groups are asked to take 40mg dexamethasone per os once a day (the first 4 days, 9 ~ 12 days and 17 ~ 20 days) during the first four 28-day-cycle.
After the first 4 cycles, the dose of dexamethasone is reduced to 40mg per os once a day during the first 4 days of every 28-day cycle. In both studies, treatment is continued until the disease is progressed.
In both studies, the dose is allowed to be adjusted in accordance with clinical and laboratory checking results. The dose is allowed to be reduced to 15mg/day, 10mg/day and 5mg/day because of the toxic reaction.
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