KPD Consolidation After ASCT in NDMM Patients

Phase 2

Recruiting

• Conditions: Multiple Myeloma, Newly Diagnosed
• Interventions: Drug: KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation

• Registration Number: NCT06879379
• Lead Sponsor: Peking University People's Hospital

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.

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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KPD consolidation	KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation	KPD consolidation therapy for 2 cycles, followed by maintenance

Primary Outcome Measures

Name	Time	Method
Minimal residual disease (MRD) negativity rate prior to maintenance therapy	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).
Overall Response Rate (ORR)	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。

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	36 months	Time interval from ASCT to disease progression or death.
Overall Survival (OS)	36 months	Time interval from ASCT to death

Trial Locations

Locations (3)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Fuxing Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China