Multiple Myeloma Clinical Trial
Official title:
RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma
Multiple myeloma (MM) is a common malignant hematology disease. The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) significantly improved the survival of MM patients. IMiDs have multiple effects in MM therapy. Except for direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. Lenalidomide, a kind of IMiDs, was usually used in the therapy of relapsed/refractory MM. The efficacy and safety of RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM still needs to be further validated.
The therapy regimens of MM were very limited before 2000, mainly including VAD (vincristine,
doxorubicin, dexamethasone), methylpheniram, corticosteroids and autologous stem cell
transplantation (ASCT). The development of proteasome inhibitors (PIs) and immunomodulatory
drugs (IMiDs) in the 2000's significantly improved the survival of MM patients. Combined
chemotherapy containing new drugs has become the first-line therapy for the treatment of
newly diagnosed MM patients.
In addition to direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. The
effects on immune system include reducing TNF-α, IL-1β, IL-6 and IL-12, increasing production
of IL-2 and IFN-γ, increasing T cell initiation, enhancing the absorption of tumor antigen by
dendritic cells (DCs), enhancing the efficiency of antigen presentation, inhibiting
regulatory T cells (Treg), and enhancing the activity of natural killer cells (NK) and NKT
cells. Lenalidomide, a kind of IMiDs, also have the effects on osteoclasts, which are
important in bone disease in MM patients.
In 2006, the combination of lenalidomide and dexamethasone (RD) was approved in the United
States for the treatment of relapsed/refractory MM. The RD regimen was approved for the
treatment of newly diagnosed MM patients in 2015. Four lenalidomide-containing triple drug
regimens were approved for the treatment of relapsed/refractory MM from 2015 to 2016.
However, the application of lenalidomide-containing triple drug regimens in newly diagnosed
patients with multiple myeloma needs to be further validated. Therefore, we designed the
randomized controlled clinical study and aimed to compare the efficacy and safety between RDD
(lenalidomide, pegylated liposomal doxorubicin, dexamethasone) and VDD (bortezomib, pegylated
liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM.
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