- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07709884
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
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
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Chengcheng Fu
- Numero di telefono: 13962191404
- Email: fuzhengzheng@suda.edu.cn
Luoghi di studio
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Jiangsu
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Suzhou, Jiangsu, Cina, 215000
- First Affiliated Hospital, Soochow University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: SonKRd
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.
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Sotoclax 320mg, d1~d28
Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡)
Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function)
Dexamethasone 40mg (halved for patients aged >75 years), d1, d8, d15, d22, 28 days/cycle,
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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MRD negative rate
Lasso di tempo: Completion of consolidation therapy, an average of 1 year
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the rate of minimal residual disease negativity
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Completion of consolidation therapy, an average of 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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overall response rate
Lasso di tempo: after completion of induction therapy and consolidation therapy, an average of 1 year
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the rate of overall response
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after completion of induction therapy and consolidation therapy, an average of 1 year
|
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CR rate
Lasso di tempo: after completion of induction therapy and consolidation therapy, an average of 1 year
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the rate of complete response
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after completion of induction therapy and consolidation therapy, an average of 1 year
|
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One-year continuous MRD negative rate
Lasso di tempo: after the first time of MRD negative, an average of 1 year
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One-year continuous MRD negative rate
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after the first time of MRD negative, an average of 1 year
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PFS
Lasso di tempo: from enrollment to completion of 2 year maintenance therapy
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Progression-free survival
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from enrollment to completion of 2 year maintenance therapy
|
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adverse events
Lasso di tempo: from enrollment to completion of following up, about 2 years]
|
the rate of adverse events and grade of adverse events
|
from enrollment to completion of following up, about 2 years]
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Acidi carbossilici
- Composti policiclici
- Piperidine
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Incintadienetrioli
- Ftalimides
- Acidi ftalici
- Acidi, carbociclico
- Piperidoni
- Isoindoli
- Lenalidomide
- Desametasone
- carfilzomib
Altri numeri di identificazione dello studio
- SonKRd
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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