Actively Recruiting
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-12
59
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)
CONDITIONS
Official Title
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed multiple myeloma, may have received up to one cycle of bortezomib-containing treatment for urgent symptoms
- Age 18 years or older
- Presence of measurable disease with specific protein or tumor size levels
- ECOG physical status score 2 or less
- High-risk genetic abnormalities or advanced disease stage as defined by guidelines
- Bone marrow function with neutrophils 1.0 x 10^9/L or higher and platelets 70 x 10^9/L or higher (or 50 x 10^9/L if plasma cells ≥ 50%)
- Liver enzymes (AST, ALT, ALP) not exceeding 3 times normal limits and bilirubin not exceeding twice normal
- Creatinine clearance of at least 40 mL/min
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during and one year after treatment
- Signed informed consent for chemotherapy or legal representative consent if participant cannot sign
You will not qualify if you...
- Monoclonal gammopathy of undetermined significance, smoldering myeloma, or primary light chain amyloidosis with organ involvement
- Diagnosis or treatment of another cancer within one year prior to enrollment or presence of residual disease from previous cancer
- Other health conditions that interfere with trial participation such as uncontrolled infections or heart/lung disease
- Peripheral neuropathy grade 1-2 with pain within 30 days before enrollment
- Major surgery within 14 days before enrollment
- Uncontrolled cardiovascular disease including hypertension, arrhythmias, heart failure, or unstable angina
- Chronic obstructive pulmonary disease with FEV1 below 50%, persistent asthma, or recent asthma history within two years
- Moderate to severe kidney insufficiency with creatinine clearance below 40 mL/min
- Known HIV infection
- Positive Hepatitis B surface antigen or active hepatitis B infection
- Known or suspected active hepatitis C infection
- Medical or psychiatric conditions that could interfere with treatment completion
- Known allergy or intolerance to study drugs
- Inability to comply with study procedures
- Pregnancy, breastfeeding, or refusal to use adequate contraception if of childbearing potential
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
C
Chengcheng Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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