Tests extra carfilzomib, pomalidomide and dexamethasone after stem cell transplant in myeloma
Tests extra KPD drug treatment after transplant in adults newly diagnosed with multiple myeloma.
Plain-language title generated from the registry record
Registry title: KPD Consolidation After ASCT in NDMM Patients
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 3 sites
- Phase
- Phase 2/3
Where in China
- Fuxing Hospital affiliated to Capital Medical UniversityBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Shanghai Changzheng HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06879379
- Record updated
- 17 March 2025
- Original description
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.Read full original descriptionShow less
A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients
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.
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 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 concurrent or suspected central nervous system infiltration; Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes); 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 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 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; Any other conditions deemed by the investigator as unsuitable for enrollment; Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma; Pregnant or lactating women.