Actively Recruiting
Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-04-16
54
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma
CONDITIONS
Official Title
Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed ultra high-risk multiple myeloma, defined as at least two adverse genetic markers, extramedullary multiple myeloma, or primary plasma cell leukemia
- No prior systemic therapy for multiple myeloma; prior bisphosphonates or localized radiation allowed
- Age between 18 and 70 years
- Fit for intensive chemotherapy and autologous stem cell transplantation as determined by a clinician
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 before induction therapy
You will not qualify if you...
- No evidence of high-risk disease
- Primary diagnosis of Waldenstrom's disease, POEMS syndrome, or light chain amyloidosis
- Previous therapy for multiple myeloma
- Prior or concurrent invasive cancers
- ECOG performance status score greater than 2 before induction therapy
- Allergies or intolerance to study drugs including daratumumab, carfilzomib, lenalidomide, dexamethasone, cisplatin, epirubicin, cyclophosphamide, melphalan, or etoposide
- Contraindications to thromboprophylaxis
- Uncontrolled or severe heart or lung disease
- Platelet count below 50,000/µL, neutrophil count below 1000/µL, or hemoglobin below 60 g/L before induction therapy
- Kidney function with creatinine clearance under 30 mL/min or liver enzymes above specified limits
- Known HIV, active hepatitis B or C infection
- Heart ejection fraction below 45% or lung function under 50% of predicted
- Uncontrolled serious medical or psychiatric conditions interfering with treatment
- Medical conditions making study drug use unsafe per investigator
- Pregnant or breastfeeding women, or those planning pregnancy during or within 6 months after treatment; men planning to father a child during or within 6 months after treatment
- Use of investigational drugs or devices within 4 weeks before study entry or current participation in another investigational study
- Major surgery within 2 weeks before study or planned surgery during study participation (kyphoplasty or vertebroplasty excluded)
- Inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
C
Chunyan Sun, MD
CONTACT
J
Jian Xu, MD
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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