Status:
RECRUITING
KPD Consolidation After ASCT in NDMM Patients
Lead Sponsor:
Peking University People's Hospital
Conditions:
Multiple Myeloma, Newly Diagnosed
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ma...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT06879379
Start Date
March 1 2025
End Date
March 1 2029
Last Update
March 17 2025
Active Locations (3)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100045
3
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 021