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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SonKRd | Experimental | All participants, including newly diagnosed patients eligible for transplantation, will receive a treatment regimen consisting of Son in combination with carfilzomib, lenalidomide, and dexamethasone (KRd): Son 320mg, days 1 to 28; carfilzomib 56mg/m2, days 1, 8, and 15 (C1d1 20 mg/m2); lenalidomide 25mg, days 1 to 21 (lenalidomide dose adjusted based on renal function); dexamethasone 40mg (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotoclax | Drug | Sotoclax 320mg, d1~d28 |
| |
| Carfilzomib |
| Measure | Description | Time Frame |
|---|---|---|
| MRD negative rate | the rate of minimal residual disease negativity | Completion of consolidation therapy, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | the rate of overall response | after completion of induction therapy and consolidation therapy, an average of 1 year |
| CR rate | the rate of complete response |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengcheng Fu | Contact | 13962191404 | fuzhengzheng@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Soochow University | Suzhou | Jiangsu | 215000 | China |
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| Drug |
Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡) |
|
| Lenalidomide | Drug | Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function) |
|
| Dexamethasone | Drug | Dexamethasone 40mg (halved for patients aged >75 years), d1, d8, d15, d22, 28 days/cycle, |
|
| 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 | after the first time of MRD negative, an average of 1 year |
| PFS | Progression-free survival | from enrollment to completion of 2 year maintenance therapy |
| adverse events | the rate of adverse events and grade of adverse events | from enrollment to completion of following up, about 2 years] |
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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