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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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

Qualifiers

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.

Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.

Aged 18 years to 70 years.

Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).

Disqualifiers

No evidence of high-risk disease.

Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis.

Received therapy for multiple myeloma.

Prior or concurrent invasive malignancies.

Trial design

Treatments tested in this trial

  • Daratumumab
  • Carfilzomib
  • Lenalidomide
  • Dexamethasone
  • Cisplatin
  • epirubicin
  • Cyclophosphamide
  • Etoposide
  • Melphalan
  • ASCT
  • bortezomib

Treatment groups

54 Participants
are divided into 1 treatment group