NCT06879379 KPD Consolidation After ASCT in NDMM Patients
| NCT ID | NCT06879379 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Peking University People's Hospital |
| Condition | Multiple Myeloma, Newly Diagnosed |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2025-03 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 202 participants in total. It began in 2025-03 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jin Lu, M.D.
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06879379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma, Newly Diagnosed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06879379 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06879379 currently recruiting?
Yes, NCT06879379 is actively recruiting participants. Contact the research team at dxldw@163.com for enrollment information.
Where is the NCT06879379 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Shanghai, China.
Who is sponsoring the NCT06879379 clinical trial?
NCT06879379 is sponsored by Peking University People's Hospital. The principal investigator is Jin Lu, M.D. at Peking University People's Hospital. The trial plans to enroll 202 participants.