The goal of this study is to evaluate treatment of newly diagnosed multiple myeloma patients with t(11;14) suitable for transplantation using the SonKRd regimen, consisting of Sodium Thiotepa, Caffizotide, Lenalidomide, and Dexamethasone. Main objectives is to evaluate the MRD negative rate in newly diagnosed multiple myeloma patients with t(11;14) who are eligible for transplantation, treated with the SOTOKLA combined with KRd regimen. And the secondary objective is to evaluate the ORR, CR rate, 1-year sustained MRD negative rate, 2-year PFS rate, and safety of the SOTOLA combined with KRd treatment regimen in newly diagnosed multiple myeloma patients with t(11;14) who are suitable for transplantation.
This study is a single-center, single-arm, prospective clinical trial. All participants, including newly diagnosed patients eligible for transplantation, will receive a treatment regimen combining Son with carfilzomide, lenalidomide, and dexamethasone (KRd): Son 320 mg, days 1 to 28; carfilzomide 56 mg/m2, days 1, 8, and 15 (C1d1 20 mg/m2); lenalidomide 25 mg, days 1 to 21 (lenalidomide dose adjusted based on renal function); and dexamethasone 40 mg (halved for patients aged \>75 years), days 1, 8, 15, and 22, with a 28-day cycle, for a total of 8 treatment cycles. Patients are allowed to receive one course of VRD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sotoclax 320mg, d1\~d28
Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡)
Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function)
Dexamethasone 40mg (halved for patients aged \>75 years), d1, d8, d15, d22, 28 days/cycle,
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China
MRD negative rate
the rate of minimal residual disease negativity
Time frame: Completion of consolidation therapy, an average of 1 year
overall response rate
the rate of overall response
Time frame: after completion of induction therapy and consolidation therapy, an average of 1 year
CR rate
the rate of complete response
Time frame: after completion of induction therapy and consolidation therapy, an average of 1 year
One-year continuous MRD negative rate
One-year continuous MRD negative rate
Time frame: after the first time of MRD negative, an average of 1 year
PFS
Progression-free survival
Time frame: from enrollment to completion of 2 year maintenance therapy
adverse events
the rate of adverse events and grade of adverse events
Time frame: from enrollment to completion of following up, about 2 years]
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