KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
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.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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。
Trial sites (3)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
Fuxing Hospital affiliated to Capital Medical University
Beijing
Beijing Municipality
Recruiting
Shanghai Changzheng Hospital
Shanghai
Shanghai Municipality
Recruiting
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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