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Newly Diagnosed Multiple MyelomaPhase 4NCT07709884

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 Phase 4 study testing Sotoclax, Carfilzomib and Lenalidomide in people with Newly Diagnosed Multiple Myeloma and T(11;14), run by The First Affiliated Hospital of Soochow University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotoclax, Carfilzomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jul 2026to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chengcheng Fu contact

13962191404

fuzhengzheng@suda.edu.cn

China1 site

  • First Affiliated Hospital, Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Sotoclax, Carfilzomib, Lenalidomide, Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotoclaxDrug

    Sotoclax 320mg, d1~d28

  • CarfilzomibDrug

    Carfilzomib 56mg/㎡, d1, d8, d15 (C1d1 20 mg/㎡)

  • LenalidomideDrug

    Lenalidomide 25mg, d1-d21 (adjust the dose of lenalidomide according to renal function)

  • DexamethasoneDrug

    Dexamethasone 40mg (halved for patients aged >75 years), d1, d8, d15, d22, 28 days/cycle,

Study groups in NCT07709884
Study groupRoleWhat they receive
SonKRdExperimentalAll 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.
Receives: Drug: Sotoclax; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD negative rate

    the rate of minimal residual disease negativity

    Measured: Completion of consolidation therapy, an average of 1 year

Secondary outcomes (5)

  1. overall response rate

    the rate of overall response

    Measured: after completion of induction therapy and consolidation therapy, an average of 1 year

  2. CR rate

    the rate of complete response

    Measured: 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

    Measured: after the first time of MRD negative, an average of 1 year

  4. PFS

    Progression-free survival

    Measured: from enrollment to completion of 2 year maintenance therapy

  5. adverse events

    the rate of adverse events and grade of adverse events

    Measured: from enrollment to completion of following up, about 2 years]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709884
Sponsor's protocol ID
SonKRd
Status last verified
Jul 2026
First submitted
27 Jun 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sotoclax, Carfilzomib and Lenalidomide in people with Newly Diagnosed Multiple Myeloma and T(11;14), run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chengcheng Fu (13962191404, fuzhengzheng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negative rate (time frame: Completion of consolidation therapy, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07709884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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