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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

ConditionsNewly Diagnosed Multiple MyelomaT(11;14)SotoclaxCarfilzomib
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Sotoclax

    Drug

    Sotoclax 320mg, d1\~d28

  • Carfilzomib

    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,

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SonKRdExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

MRD negative rate

the rate of minimal residual disease negativity

Time frame
Completion of consolidation therapy, an average of 1 year

Secondary outcomes

1

overall response rate

the rate of overall response

Time frame
after completion of induction therapy and consolidation therapy, an average of 1 year
2

CR rate

the rate of complete response

Time frame
after completion of induction therapy and consolidation therapy, an average of 1 year
3

One-year continuous MRD negative rate

One-year continuous MRD negative rate

Time frame
after the first time of MRD negative, an average of 1 year
4

PFS

Progression-free survival

Time frame
from enrollment to completion of 2 year maintenance therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: