NCT06140966 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
| NCT ID | NCT06140966 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2026-10-20 |
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 54 participants in total. It began in 2023-10-20 with a primary completion date of 2026-10-20.
⚠ 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 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
Eligibility Criteria
Inclusion Criteria: 1. Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia. 2. Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed. 3. Aged 18 years to 70 years. 4. Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion). 5. Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy. Exclusion Criteria: 1. No evidence of high-risk disease. 2. Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis. 3. Received therapy for multiple myeloma. 4. Prior or concurrent invasive malignancies. 5. Eastern Cooperative Oncology Group (ECOG) score \>2 before induction chemotherapy. 6. Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide. 7. Participants with contraindication to thromboprophylaxis. 8. Any uncontrolled or severe cardiovascular or pulmonary disease. 9. Platelet count \< 50,000/μL, absolute neutrophil count \<1000/μL, and haemoglobin \<60 g/L before induction chemotherapy. 10. Calculated creatinine clearance \<30 mL/min, alanine transaminase (ALT) or aspertate aminotransferase (AST) \>3 times upper limit of normal (ULN). Bilirubin \>2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin \>2.0 times ULN). 11. Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C. 12. Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies \<50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \< 50% of predicted. 13. Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. 14. Known/underlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous. 15. Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who plans to father a child while taking part in this trial or within at least 6 months after the last dose of trial treatment. 16. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study. 17. Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery. 18. Known or suspected of not being able to comply with the study protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06140966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Myeloma. 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 NCT06140966 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 NCT06140966 currently recruiting?
Yes, NCT06140966 is actively recruiting participants. Contact the research team at suncy0618@163.com for enrollment information.
Where is the NCT06140966 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06140966 clinical trial?
NCT06140966 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 54 participants.