Evaluating a new treatment for ultra high-risk multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and safety of a treatment regimen combining daratumumab and carfilzomib-based induction, consolidation, and maintenance therapy in patients with ultra high-risk, newly diagnosed multiple myeloma. Participants will undergo 2-4 cycles of induction therapy followed by autologous stem cell transplantation (ASCT), consolidation therapy, and then maintenance therapy. The goal is to improve survival outcomes for patients who are typically less responsive to existing treatments. The study focuses on patients with specific high-risk characteristics, including 'double-hit' multiple myeloma and primary plasma cell leukemia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Chunyan Sun, MD
• Email: suncy0618@163.com
• Phone: +8602785726387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma

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• Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant

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• Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.