Actively Recruiting
KPD Consolidation After ASCT in NDMM Patients
Led by Peking University People's Hospital · Updated on 2025-03-17
202
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KPD Consolidation After ASCT in NDMM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed multiple myeloma eligible for transplantation
- Received upfront triplet or quadruplet induction regimen
- Received upfront autologous stem cell transplantation after induction
- ECOG performance status score less than 2
- Adequate organ function including ALT/AST 64 2.5 x upper limit of normal, total bilirubin 64 1.5 x upper limit of normal (or direct bilirubin 64 1.5 x upper limit if congenitally high), left ventricular ejection fraction 65%, and basal oxygen saturation above 95% on room air
- Women of childbearing potential must agree to effective contraception during and after study drug use; men with fertile partners must agree to use barrier contraception
- Willing and able to comply with study procedures and provide written informed consent
You will not qualify if you...
- Diagnosis of primary plasma cell leukemia or POEMS syndrome
- Diagnosis of primary amyloidosis, Waldenstr�f6m's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
- Severe mental disorders, altered mental status, or central nervous system diseases including seizures, stroke, dementia, cerebellar disease, or autoimmune CNS diseases
- History of genetic bone marrow failure syndromes such as Fanconi anemia, Shwachman-Diamond syndrome, or Costello syndrome
- Diagnosis or treatment for another malignancy within 1 year before randomization, or residual disease from previous malignancy (excluding certain skin and carcinoma in situ cancers)
- Active infections including HIV or hepatitis B or C
- Known allergy to study drugs or their components
- Concurrent or suspected central nervous system infiltration
- Conditions interfering with study participation or outcome assessment
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
3
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 021
Actively Recruiting
Research Team
X
Xuelin Dou, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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