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

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06140966
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.
  • Carfilzomib — DRUG
    Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.
  • Lenalidomide — DRUG
    Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.
  • Dexamethasone — DRUG
    Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance
  • Cisplatin — DRUG
    Given by vein: days 1-4 of each Induction cycle
  • epirubicin — DRUG
    Given by vein: days 1-4 of each Induction cycle
  • Cyclophosphamide — DRUG
    Given by vein: days 1-4 of each Induction cycle
  • Etoposide — DRUG
    Given by vein: days 1-4 of each Induction cycle
  • Melphalan — DRUG
    Given by vein: day -1 of Transplant
  • ASCT — PROCEDURE
    day 0 of Transplant
  • bortezomib — DRUG
    given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy

Study Details

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

Key Dates

Start date
Oct 20, 2023
Status verified
Apr 2025
Primary completion
Oct 20, 2026
Completion
Oct 20, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment
    Pretrial induction chemotherapy (if required): bortezomib, cyclophosphamid, dexamethasone (VCD). Induction Chemotherapy: Daratumumab, Carfilzomib,Lenalidomide, Dexamethasone, CisPlatin, epirubicin, Cyclophosphamide and Etoposide (Dara-KRd-PACE). Autologous Stem Cell Transplant (ASCT) : Melphalan, ASCT. Consolidation: Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone (Dara-KRd). Maintenance: Daratumumab, Carfilzomib, and Dexamethasone (Dara-Kd).

Primary Outcome Measure

2-year progression-free survival [ Time Frame: 24 months ]

Central Contacts

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