KPD Consolidation After ASCT in NDMM Patients

March 14, 2025 updated by: Jin Lu, MD, Peking University People's Hospital

A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients

This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple myeloma (MM) is a malignancy characterized by abnormal proliferation of plasma cells, leading to organ damage and poor prognosis. Despite advances in treatment, including autologous stem cell transplantation (ASCT), the disease remains incurable for most patients. Post-transplant consolidation and maintenance therapies have emerged as critical strategies to deepen remission and prolong progression-free survival (PFS). However, the role of consolidation therapy remains debated. This study aims to clarify whether KPD consolidation therapy after ASCT provides additional benefits compared to direct maintenance therapy.

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xuelin Dou, M.D.
  • Phone Number: +86-010-8649-1513
  • Email: dxldw@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Xuelin Dou
          • Phone Number: 7003 +86-010-82816999
          • Email: dxldw@163.com
        • Principal Investigator:
          • Jin Lu
      • Beijing, Beijing, China, 100045
        • Recruiting
        • Fuxing Hospital affiliated to Capital Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
          • Wanting Qiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Newly diagnosed MM eligible for transplantation.
  • Received upfront triplet or quadraplet induction regimen.
  • Received upfront ASCT after induction.
  • ECOG score < 2.

  • Adequate Organ Function Reserve:

    1. Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
    2. Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
    3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
    4. Basal oxygen saturation > 95% in room air;
  • Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;
  • The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.

Exclusion Criteria:

  • Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
  • Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
  • Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia/ hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the CNS;
  • Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;
  • Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with any type of non-melanoma skin cancer or completely resected carcinoma in situ);
  • Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;
  • Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;
  • Patients with concurrent or suspected central nervous system infiltration;
  • Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;
  • Pregnant or lactating women;
  • Any other conditions deemed by the investigator as unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KPD consolidation
KPD consolidation therapy for 2 cycles, followed by maintenance
Drug: KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
After post-transplant randomization, patients will receive either KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation then maintenance or no consolidation and maintenance.
No Intervention: No consolidation
Direct maintenance without consolidation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease (MRD) negativity rate prior to maintenance therapy
Time Frame: 36 months
The primary endpoint of this study is to compare the minimal residual disease (MRD) negativity rate prior to maintenance therapy in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients who receive KPD consolidation therapy versus those who do not receive consolidation therapy after triplet or quadraplet induction therapy and autologous stem cell transplantation (ASCT).
36 months
Overall Response Rate (ORR)
Time Frame: 36 months
Compare the overall response rate (ORR) including the rates of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR), prior to maintenance therapy according to the IMWG (International Myeloma Working Group) assessment criteria, between the two treatment groups。
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 36 months
Time interval from ASCT to disease progression or death.
36 months
Overall Survival (OS)
Time Frame: 36 months
Time interval from ASCT to death
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Jin Lu, M.D., Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PHB165-001-202501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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