A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnose… (NCT07709884) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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
China20 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosed as active multiple myeloma according to the diagnostic criteria outlined in the "Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2024 Revision)";
. Aged 18 or above, male or female;
. Initial diagnosis of multiple myeloma;
. The FISH test confirmed by a third-party laboratory is positive for t(11;14) or the previous FISH test report is positive for t(11;14);
. ECOG score of 0-2;
. Possessing the following organ function conditions, defined as:
. Expected survival period is greater than 6 months; The patient understands the purpose and procedures of this trial, voluntarily participates in it, and signs a written informed consent form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MRD negative rate
Timeframe: Completion of consolidation therapy, an average of 1 year
Trial details
NCT IDNCT07709884
SponsorThe First Affiliated Hospital of Soochow University
. Have received any experimental drug treatment within 2 weeks;
. Secondary plasma cell leukemia;
. Transmyocardial amyloidosis with heart failure and arrhythmia;
. Creatinine clearance rate \< 30 ml/min;
. Simultaneous presence of other tumors or a history of tumor, or having undergone anti-tumor treatment (including major surgery) within the last 3 weeks, except for the following tumor diseases or those who have been tumor-free for ≥3 years to date: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM clinical stage T1a or T1b), or previously treated prostate cancer;
. Accompanied by mental illnesses requiring inpatient treatment in psychiatric hospitals or controlled institutions, as well as continuous and frequent outpatient treatment, or exhibiting a dependent cognitive state that cannot be controlled by caregivers (confirmed by a specialist physician);
. Accompanied by severe pulmonary infection, skin and soft tissue infection, or urinary tract infection;
. Patients experiencing unstable angina pectoris or myocardial infarction, heart failure NYHA class III or IV, uncontrolled severe coronary artery disease, uncontrolled severe ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or third-degree conduction block within 4 months prior to enrollment, except for those with a cardiac pacemaker;