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NOT YET RECRUITING
NCT07709884
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

Sotoclax

Sotoclax 320mg, d1\~d28

DRUG

Carfilzomib

Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡)

DRUG

Lenalidomide

Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function)

DRUG

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