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A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen
Sponsor: The First Affiliated Hospital of Soochow University
Summary
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.
Official title: A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen, Consisting of Sodium Oxychloride, Caffizyme, Lenalidomide and Dexamethasone
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-07-01
Completion Date
2028-12-31
Last Updated
2026-07-17
Healthy Volunteers
No
Interventions
Sotoclax
Sotoclax 320mg, d1\~d28
Carfilzomib
Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡)
Lenalidomide
Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function)
Dexamethasone
Dexamethasone 40mg (halved for patients aged \>75 years), d1, d8, d15, d22, 28 days/cycle,
Locations (1)
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China