Multiple Myeloma Clinical Trial
Official title:
A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction & consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)
Daratumumab, carfilzomib, lenalidomide and dexamethasone are commonly used drugs for multiple myeloma. The efficacy of their combination has been proven in newly diagnosed multiple myeloma patients, including high-risk patients, while there are no relevant data in the Chinese population. Therefore, the efficacy of DKRd regimen in Chinese HR-NDMM patients needs to be further explored. It is a prospective, single-arm study. High risk(HR)-NDMM Patients with will be recruited and their baseline data will be collected. Patients will be treated with bortezomib, lenalidomide and dexamethasone for the first cycle in order to urgently relieve bone pain, renal insufficiency, hypercalcemia and other symptoms, during which screening and evaluation is conducted. And then patients will be treated with 3 cycles of daratumumab, carfilzomib (K) lenalidomide (R) combined with dexamethasone (d), after which stem cells were collected from transplant-eligible, followed by autologous hematopoietic stem cell transplantation, two cycles of DKRD consolidation, DKR maintenance treatment for more than one year. If continuous MRD negativity for more than one year, patients will be treated with only lenalidomide maintenance. Transplant-noneligible patients will be treated with DKRD for 4-cycles consolidation therapy without transplantation, and then entered DKR maintenance therapy. If patients with continuous MRD negativity for more than one year will be treated with only lenalidomide maintenance. Follow-up was conducted and outcome indicators were collected to explore the efficacy and safety of DKRd treatment in HR-NDMM patients. The results of this study are expected to provide new treatment options and corresponding dosages for Chinese HR-NDMM patients, thereby improving patient outcomes and reducing the overall disease burden. ;
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