Newly DiagnosedPhase 4NCT06409702

Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

A Phase 4 study testing Carfilzomib, Daratumumab and Lenalidomide in people with Newly Diagnosed and High Risk, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Newly Diagnosed, High Risk, MRD
What is being tested?: Carfilzomib, Daratumumab and Lenalidomide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteChina
Study dates: 12 Jun 2024to 31 Dec 2027
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

patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;
age ≥ 18 years;
have an evaluable lesion; serum M protein ≥ 10 g/L, or urinary light chain ≥ 200 mg/24h, or involved serum free light chain (FLC) ≥ 100 mg/L, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules can be measured with a manual tape, and extramedullary tumor SPD of extramedullary tumors is measured on a CT scan as the product of the largest dimension of the largest pendulous diameter of the lesion (minimum diameter of 5mm or more), parosteal lesions need to be in soft tissue outside the bone cavity to meet the above criteria. MRI measures the size of an extramedullary tumor as the product of the maximum pendulous diameter at the level of the largest area of the tumor (minimum diameter of 5mm or more)
ECOG physical status score ≤ 2
or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined
or R-ISS stage 3

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or combined plasma cell leukemia (defined as peripheral blood sorted clonal plasma cells ≥ 5%)
bone marrow function: neutrophils ≥ 1.0 x 109 /L, platelets ≥ 70 x 109 /L (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 109 /L)
AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value;
serum creatinine clearance ≥ 40mL/min
negative pregnancy test for women of childbearing age; patients and their spouses must agree to use effective contraception during the treatment period and the following one-year period;
Signed informed consent for chemotherapy. A legal representative will sign the informed consent form if the subject is unable to sign it due to impaired consciousness, paralysis of the subject's upper limbs, or inability to write.

Who cannot join

monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.
diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.
other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any adjuvant therapy considered investigational.
peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration
major surgery within 14 days prior to pre-registration
evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension (hypertension defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg on 3 non-same day office measurements without antihypertensive medication), arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24 h ventricular premature load ≥ 15% of the total number of heart beats, atrioventricular block, heart rate <30-40 bpm), congestive heart failure, unstable angina or myocardial infarction. New York Heart Association (NYHA) Class III, IV heart failure.

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Participants with known chronic obstructive pulmonary disease (COPD) (defined as exertional expiratory volume in 1 second [FEV1] <50% of predicted normal volume), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma is permitted). Participants with known or suspected COPD must have FEV1 testing during screening.
moderate/severe renal insufficiency: creatinine clearance < 40mL/min.
known human immunodeficiency virus (HIV) positivity.
Hepatitis B seropositivity (defined as a positive Hepatitis B surface antigen [HBsAg] test). Subjects whose infection has resolved (i.e., subjects who are HBsAg negative but positive for Hepatitis B Core Antigen Antibody [anti-HBc] and/or Hepatitis B Surface Antigen Antibody [anti-HBs]) must be screened for Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) levels using real-time Polymerase Chain Reaction (PCR). PCR-positive subjects will be excluded. Exception:Subjects with serologic results suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
known or suspected active hepatitis C infection.
any medical or psychiatric condition that, in the opinion of the investigator, may interfere with the completion of treatment under this protocol.
known allergy or intolerance to the test drug.
inability to comply with the protocol/procedure.
Subjects will be ineligible to participate in the trial because the genotoxic, mutagenic, and teratogenic effects of the investigational drug(s) involved in this trial on the developing fetus and neonate are unknown if any of the following conditions are present at the time of screening: Pregnant women, lactating mothers, males or females of childbearing potential who refuse adequate contraception (as per protocol).

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

15206138158

793877006@qq.com

China1 site, 1 recruiting

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Chengcheng Fu, Ph D, 13962191404
Recruiting

Other trials in China

About this study

Official title: A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)

Read the detailed description

Daratumumab, carfilzomib, lenalidomide and dexamethasone are commonly used drugs for multiple myeloma. The efficacy of their combination has been proven in newly diagnosed multiple myeloma patients, including high-risk patients, while there are no relevant data in the Chinese population. Therefore, the efficacy of DKRd regimen in Chinese HR-NDMM patients needs to be further explored.

It is a prospective, single-arm study. High risk(HR)-NDMM Patients with will be recruited and their baseline data will be collected. Patients will be treated with bortezomib, lenalidomide and dexamethasone for the first cycle in order to urgently relieve bone pain, renal insufficiency, hypercalcemia and other symptoms, during which screening and evaluation is conducted. And then patients will be treated with 3 cycles of daratumumab, carfilzomib (K) lenalidomide (R) combined with dexamethasone (d), after which stem cells were collected from transplant-eligible, followed by autologous hematopoietic stem cell transplantation, two cycles of DKRD consolidation, DKR maintenance treatment for more than one year. If continuous MRD negativity for more than one year, patients will be treated with only lenalidomide maintenance. Transplant-noneligible patients will be treated with DKRD for 4-cycles consolidation therapy without transplantation, and then entered DKR maintenance therapy. If patients with continuous MRD negativity for more than one year will be treated with only lenalidomide maintenance. Follow-up was conducted and outcome indicators were collected to explore the efficacy and safety of DKRd treatment in HR-NDMM patients. The results of this study are expected to provide new treatment options and corresponding dosages for Chinese HR-NDMM patients, thereby improving patient outcomes and reducing the overall disease burden.

Conditions: Newly Diagnosed, High Risk, MRD, Multiple Myeloma
Being tested: Carfilzomib, Daratumumab, Lenalidomide, Dexamethasone, VRD for first-cycle induction therapy
Medical subject headings: Multiple Myeloma

What participants receive

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

CarfilzomibDrug
Also called Kyprolis
Induction:
ASCT：20mg/56mg/m2 ,D1,8,15，C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15，C2-4;
Consolidation:
ASCT: 56mg/m2 ,D1,8,15，C5-6; non ASCT: 36mg/m2 ,D1,8,15，C5-8;
Maintenance:
ASCT: 70mg/m2 ，D1，15; non-ASCT：56mg/m2 ，D1，15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued
DaratumumabDrug
Also called Darzalex
28d/Cycle
Induction:
16mg/kg, D1,8,15,22，C 2-3，16mg/kg, D1,15, C4;
Consolidation:
ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8;
Maintenance:
16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued
LenalidomideDrug
28d/Cycle
Induction:
25mg qd d1-21 C2-C4;
Consolidation:
ASCT: 10mg d1-21，C5-6; non ASCT: 25 mg d1-21，C5-8;
Maintenance: 10mgqd D1-21
After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression
DexamethasoneDrug
28d/Cycle
Induction:
ASCT：40mg qd, po/iv，D1,8,15,22，C2-4; non ASCT:20mg qd, po/iv，D1,8,15,22，C2-4;
Consolidation:
ASCT: 40mg qd, po/iv，D1,8,15,22，C5-6; non ASCT:20mg qd, po/iv，D1,8,15,22，C5-8
VRD for first-cycle induction therapyDrug
Also called Bortezomib(V), Lenalidomide(R), Dexamethasone(D)
Induction:
C1, 28d/cycle Bortezomib(V）:1.3 mg/m2，H，d1、4、8、11； Lenalidomide(R)：25mg，po. qd d1-14; Dexamethasone(D)：20 mg，po/iv，D1，2, 4，5, 8，9, 11,12。

Study groups in NCT06409702
Study group	Role	What they receive
DKRd	Experimental	All patients will be treated with VRD induction for first-cycle,and then DKRD induction and consolidation therapy for following 5~7 cycles, then maintenance therapy. Receives: Drug: Carfilzomib; Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: VRD for first-cycle induction therapy

What is being measured

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

MRD negative rate
the rate of minimal residual disease negativity
Measured: Completion of consolidation therapy

Secondary outcomes (5)

≥VGPR rate
the rate of very good partial response or better
Measured: after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
overall response rate
the rate pf overall response
Measured: after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
adverse events
the rate of adverse events and grade of adverse events
Measured: from enrollment to completion of following up, about 2 years
PFS
Progression-free survival
Measured: from enrollment to completion of one-year maintenance therapy
OS
overall survival
Measured: from enrollment to completion of one-year maintenance therapy

Timeline

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

12 Jun 202431 Dec 2027

First posted10 May 2024
Study start12 Jun 2024
Primary completion30 Nov 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Newly DiagnosedStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 59 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06409702
Sponsor's protocol ID: DKRD-MM11
Status last verified: Jun 2025
First submitted: 16 Apr 2024
Last updated: 12 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
ClinicalTrials.gov ID: NCT06409702
Acronym / sponsor ID: DKRD-MM11
Conditions: Newly Diagnosed, High Risk, MRD, Multiple Myeloma
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 59 participants (estimated)
Lead sponsor: The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
Study start: 12 Jun 2024 (actual)
Primary completion: 30 Nov 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 10 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DKRd	Experimental	Drug: Carfilzomib, Drug: Daratumumab, Drug: Lenalidomide, Drug: Dexamethasone, Drug: VRD for first-cycle induction therapyAll patients will be treated with VRD induction for first-cycle,and then DKRD induction and consolidation therapy for following 5~7 cycles, then maintenance therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;
age ≥ 18 years;
have an evaluable lesion; serum M protein ≥ 10 g/L, or urinary light chain ≥ 200 mg/24h, or involved serum free light chain (FLC) ≥ 100 mg/L, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules can be measured with a manual tape, and extramedullary tumor SPD of extramedullary tumors is measured on a CT scan as the product of the largest dimension of the largest pendulous diameter of the lesion (minimum diameter of 5mm or more), parosteal lesions need to be in soft tissue outside the bone cavity to meet the above criteria. MRI measures the size of an extramedullary tumor as the product of the maximum pendulous diameter at the level of the largest area of the tumor (minimum diameter of 5mm or more)
ECOG physical status score ≤ 2
or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined

Key exclusion criteria (15 listed)

monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.
diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.
other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any adjuvant therapy considered investigational.
peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration
major surgery within 14 days prior to pre-registration

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarfilzomibAlso: KyprolisInduction: ASCT：20mg/56mg/m2 ,D1,8,15，C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15，C2-4; Consolidation: ASCT: 56mg/m2 ,D1,8,15，C5-6; non ASCT: 36mg/m2 ,D1,8,15，C5-8; Maintenance: ASCT: 70mg/m2 ，D1，15; non-ASCT：56mg/m2 ，D1，15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued	Drug	DKRd
DaratumumabAlso: Darzalex28d/Cycle Induction: 16mg/kg, D1,8,15,22，C 2-3，16mg/kg, D1,15, C4; Consolidation: ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8; Maintenance: 16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued	Drug	DKRd
Lenalidomide28d/Cycle Induction: 25mg qd d1-21 C2-C4; Consolidation: ASCT: 10mg d1-21，C5-6; non ASCT: 25 mg d1-21，C5-8; Maintenance: 10mgqd D1-21 After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression	Drug	DKRd
Dexamethasone28d/Cycle Induction: ASCT：40mg qd, po/iv，D1,8,15,22，C2-4; non ASCT:20mg qd, po/iv，D1,8,15,22，C2-4; Consolidation: ASCT: 40mg qd, po/iv，D1,8,15,22，C5-6; non ASCT:20mg qd, po/iv，D1,8,15,22，C5-8	Drug	DKRd
VRD for first-cycle induction therapyAlso: Bortezomib(V), Lenalidomide(R), Dexamethasone(D)Induction: C1, 28d/cycle Bortezomib(V）:1.3 mg/m2，H，d1、4、8、11； Lenalidomide(R)：25mg，po. qd d1-14; Dexamethasone(D)：20 mg，po/iv，D1，2, 4，5, 8，9, 11,12。	Drug	DKRd

Primary outcome

MRD negative rate
Time frame: Completion of consolidation therapy
the rate of minimal residual disease negativity

5 secondary outcomes

≥VGPR rate
Time frame: after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
overall response rate
Time frame: after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
adverse events
Time frame: from enrollment to completion of following up, about 2 years
PFS
Time frame: from enrollment to completion of one-year maintenance therapy
OS
Time frame: from enrollment to completion of one-year maintenance therapy

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Chengcheng Fu contact

15206138158

793877006@qq.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carfilzomib, Daratumumab and Lenalidomide in people with Newly Diagnosed and High Risk, 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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 (15206138158, 793877006@qq.com), 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). 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 NCT06409702.

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 12 Jun 2025.