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

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

Overview

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.

Detailed description

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.

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,

Primary outcome measures

• MRD negative rate [Time frame: Completion of consolidation therapy, an average of 1 year]

Secondary outcome measures (5)

• overall response rate [Time frame: after completion of induction therapy and consolidation therapy, an average of 1 year]
• CR rate [Time frame: after completion of induction therapy and consolidation therapy, an average of 1 year]
• One-year continuous MRD negative rate [Time frame: after the first time of MRD negative, an average of 1 year]
• PFS [Time frame: from enrollment to completion of 2 year maintenance therapy]
• adverse events [Time frame: from enrollment to completion of following up, about 2 years]]

Eligibility criteria

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:

HGB> 80g/dl Platelets > 50×10\^9/L Neutrophil count > 1×10\^9/L Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 times ULN; Creatinine clearance rate ≥ 30 mL/min Blood oxygen saturation is ≥90%;

• 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.

Exclusion criteria

• 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;
• Poorly controlled hypertension or hyperglycemia within 14 days prior to enrollment;
• Severe, uncontrolled medical disorders or active infections that may impair the subject's ability to receive the treatment specified in the protocol, including but not limited to HIV antibody-positive, syphilis antibody-positive, uncontrolled diabetes, and patients undergoing hemodialysis or peritoneal dialysis;
• Subjects with uncontrolled active or chronic liver diseases and medical histories (including but not limited to viral hepatitis, cirrhosis, non-alcoholic steatohepatitis) or subjects with significant abnormalities in liver function, or other liver-related diseases that, in the investigator's judgment, may affect drug metabolism or subject safety;
• Women who are pregnant or breastfeeding
• Situations where researchers determine that the participant is not suitable for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• First Affiliated Hospital, Soochow University — Suzhou

Identifiers

NCT: NCT07709884 · SonKRd

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗