KPD Consolidation After ASCT in NDMM Patients

Last updated: March 14, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Multiple Myeloma

Cancer

Lymphoproliferative Disorders

Treatment

KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation

Clinical Study ID

NCT06879379
2024PHB165-001-202501
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 highbilirubin, direct bilirubin must be ≤ 1.5 × UNL;

  3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed byechocardiography, 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 theperiod of using the study drug and within 3 months after the last administration ofthe study drug; and to use highly effective contraceptive measures for at least 1year thereafter. Male participants with fertile partners must agree to use effectivebarrier contraception during the period of using the study drug and within 3 monthsafter the last administration of the study drug;

  • The participant is willing and able to comply with the study procedures andvoluntarily signs the written informed consent form.

Exclusion

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 ofcentral nervous system (CNS) diseases such as epileptic seizures, cerebral vascularischemia/ hemorrhage, dementia, cerebellar diseases, or any autoimmune diseasesinvolving the CNS;

  • Patients with a history of the following genetic diseases: Fanconi anemia,Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrowfailure syndrome;

  • Patients who underwent a diagnosis or treatment for another malignancy within 1 yearprior to randomization, or had a previous diagnosis of another malignancy withevidence of residual disease (excluding patients with any type of non-melanoma skincancer 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 anyexcipients 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 mayinterfere with the participant's ability to participate in the study or theassessment of study outcomes;

  • Pregnant or lactating women;

  • Any other conditions deemed by the investigator as unsuitable for enrollment.

Study Design

Total Participants: 202
Treatment Group(s): 1
Primary Treatment: KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
Phase: 2/3
Study Start date:
March 01, 2025
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Fuxing Hospital affiliated to Capital Medical University

    Beijing, Beijing 100045
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 021
    China

    Active - Recruiting

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