NCT06879379

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
35mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2025Mar 2029

Study Start

First participant enrolled

March 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 11, 2025

Last Update Submit

March 14, 2025

Conditions

Multiple Myeloma, Newly Diagnosed

Keywords

consolidation

Outcome Measures

Primary Outcomes (2)

  • Minimal residual disease (MRD) negativity rate prior to maintenance therapy

    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)

    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 Outcomes (2)

  • Progression-free survival (PFS)

    36 months

  • Overall Survival (OS)

    36 months

Study Arms (2)

KPD consolidation

EXPERIMENTAL

KPD consolidation therapy for 2 cycles, followed by maintenance

Drug: KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation

No consolidation

NO INTERVENTION

Direct maintenance without consolidation.

Interventions

KPD (carfilzomib, pomalidomide, and dexamethasone) consolidationDRUG

After post-transplant randomization, patients will receive either KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation then maintenance or no consolidation and maintenance.

KPD consolidation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
  • Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
  • Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Fuxing Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 021, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomibpomalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jin Lu, M.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelin Dou, M.D.

CONTACT

+86-010-8649-1513dxldw@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Hematology

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

CN(3)