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Multiple MyelomaPhase 2NCT06140966

Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

A Phase 2 study testing Daratumumab, Carfilzomib and Lenalidomide in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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

This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Daratumumab, Carfilzomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
20 Oct 2023to 20 Oct 2027
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia.
  • Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.
  • Aged 18 years to 70 years.
  • Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).
  • Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.

Who cannot join

  • No evidence of high-risk disease.
  • Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis.
  • Received therapy for multiple myeloma.
  • Prior or concurrent invasive malignancies.
  • Eastern Cooperative Oncology Group (ECOG) score >2 before induction chemotherapy.
  • Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide.
Show all 18Show fewer
  • Participants with contraindication to thromboprophylaxis.
  • Any uncontrolled or severe cardiovascular or pulmonary disease.
  • Platelet count < 50,000/μL, absolute neutrophil count <1000/μL, and haemoglobin <60 g/L before induction chemotherapy.
  • Calculated creatinine clearance <30 mL/min, alanine transaminase (ALT) or aspertate aminotransferase (AST) >3 times upper limit of normal (ULN). Bilirubin >2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin >2.0 times ULN).
  • Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C.
  • Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies <50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) < 50% of predicted.
  • Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • Known/underlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous.
  • Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who plans to father a child while taking part in this trial or within at least 6 months after the last dose of trial treatment.
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study.
  • Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.
  • Known or suspected of not being able to comply with the study protocol.

Trial locations and contacts

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

Chunyan Sun, MD contact

+8602785726387

suncy0618@163.com

Jian Xu, MD contact

+8602785726006

xujian01222@163.com

China1 site, 1 recruiting

  • Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Chunyan Sun, MD, +8602785726387, suncy0618@163.com

    Jian Xu, MD, +8602785726006, xujian01222@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma

Read the detailed description

Survival outcomes for patients with newly diagnosed multiple myeloma (MM) have improved substantially in the past decades, due to the introduction of novel therapeutic strategies. Unfortunately, patients with ultra-high-risk MM, including "double-hit" MM, extramedullary MM (EMM), and primary plasma cell leukemia (pPCL), have a significantly worse prognosis and benefit less from current therapeutic strategies. This study aims to investigate whether a treatment regimen combining daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with autologous stem cell transplantation (ASCT) can improve the survival outcomes of newly diagnosed, transplant-eligible, ultra high-risk multiple myeloma patients. In the study, participants will receive induction therapy with 2-4 cycles of Dara-KRd-PACE, followed by ASCT, 4 cycles of Dara-KRd consolidation, and then maintenance with 12 cycles of Dara-Kd.

Keywords
Daratumumab, Carfilzomib, Multiple Myeloma, Ultra High-risk, Primary Plasma Cell Leukemia, Extramedullary Multiple Myeloma, Autologous stem cell transplant, Double hit
Medical subject headings
Multiple Myeloma

What participants receive

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

  • DaratumumabDrug

    Also called Darzalex

    Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.

  • CarfilzomibDrug

    Also called Kyprolis

    Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.

  • LenalidomideDrug

    Also called Revlimid

    Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.

  • DexamethasoneDrug

    Also called Baycadron

    Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance

  • CisplatinDrug

    Also called Platinol

    Given by vein: days 1-4 of each Induction cycle

  • epirubicinDrug

    Also called Pharmorubicin

    Given by vein: days 1-4 of each Induction cycle

  • CyclophosphamideDrug

    Also called Cytoxan

    Given by vein: days 1-4 of each Induction cycle

  • EtoposideDrug

    Also called Eposin

    Given by vein: days 1-4 of each Induction cycle

  • MelphalanDrug

    Also called Alkeran

    Given by vein: day -1 of Transplant

  • ASCTProcedure or surgery

    Also called autologous stem cell transplantation

    day 0 of Transplant

  • bortezomibDrug

    Also called Velcade

    given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy

Study groups in NCT06140966
Study groupRoleWhat they receive
Study TreatmentExperimentalPretrial induction chemotherapy (if required): bortezomib, cyclophosphamid, dexamethasone (VCD). Induction Chemotherapy: Daratumumab, Carfilzomib,Lenalidomide, Dexamethasone, CisPlatin, epirubicin, Cyclophosphamide and Etoposide (Dara-KRd-PACE). Autologous Stem Cell Transplant (ASCT) : Melphalan, ASCT. Consolidation: Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone (Dara-KRd). Maintenance: Daratumumab, Carfilzomib, and Dexamethasone (Dara-Kd).
Receives: Drug: Daratumumab; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Cisplatin; Drug: epirubicin; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Melphalan; Procedure: ASCT; Drug: bortezomib

What is being measured

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

  1. 2-year progression-free survival

    2-year Progression-free survival of participants as determined by investigator assessment.

    Measured: 24 months

Secondary outcomes (8)

  1. progression-free survival

    progression-free survival of participants as determined by investigator assessment.

    Measured: 36 months

  2. overall survival

    overall survival of participants as determined by investigator assessment.

    Measured: 36 months

  3. overall response rate

    Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

    Measured: 36 months

  4. minimal residual disease negativity rate

    Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing.

    Measured: 36 months

  5. complete response rate

    complete response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

    Measured: 36 months

  6. duration of minimal residual disease negativity

    determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

    Measured: 36 months

  7. duration of response

    determined by investigator assessment.

    Measured: 36 months

  8. adverse events

    graded according to the Common Terminology Criteria for Adverse Events v5

    Measured: collected until 3 months after treatment completion

Timeline

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

  1. First posted21 Nov 2023
  2. Study start20 Oct 2023
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion20 Oct 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140966
Sponsor's protocol ID
D-KRD20230808
Status last verified
Apr 2025
First submitted
14 Nov 2023
Last updated
16 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab, Carfilzomib and Lenalidomide in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 5 inclusion and 18 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 16 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Chunyan Sun, MD (+8602785726387, suncy0618@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year progression-free survival (time frame: 24 months). 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 NCT06140966.

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 16 Apr 2025.

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