Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT05675319
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Allogeneic Stem Cells — DRUG
    Allogeneic Stem Cell Transplantation
  • carfilzomib/lenalidomide/dexamethasone (KRD) — DRUG
    triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version
  • elotuzumab/lenalidomide/dexamethasone (ERD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • daratumumab/bortezomib/dexamethasone (DVD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • daratumumab/lenalidomide/dexamethasone (DRD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • ixazomib/lenalidomide/dexamethasone (IRD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • pomalidomide/bortezomib/dexamethasone (PVD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • carfilzomib/daratumumab/dexamethasone (KDD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • Autologous Stem Cells — DRUG
    Autologous Stem Cell Transplantation
  • daratumumab/pomalidomide/dexamethasone (DPD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • isatuximab/carfilzomib/dexamethasone (Isa-KD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version
  • selinexor/bortezomib/dexamethasone (SVD) — DRUG
    triple regimen for first relapse should be applied according to latest SmPC version

Study Details

Allogeneic stem cell (allo SCT) transplantation for multiple myeloma is a potential curative treatment, but is associated with morbidity and treatment related mortality. Approved drug combinations or another autologous stem cell transplantation (auto-SCT) can be used for relapsed patients resulting in a median progression free survival up to 2-3 years. In the current trial after first-line treatment relapsed or progressed myeloma patients with an HLA compatible donor will be randomized after 3 cycles of salvage therapy to allogeneic stem cell transplantation or to continuous conventional salvage therapy.

Key Dates

Start date
Mar 3, 2023
Status verified
Dec 2025
Primary completion
Mar 14, 2025
Completion
Mar 21, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (allo SCT)
    Allogeneic stem cell transplantation
  • Active Comparator: Arm B (conventional therapy)
    Currently approved triple regimens for first relapse: * carfilzomib/lenalidomide/dexamethasone (KRD) or * elotuzumab/lenalidomide/dexamethasone (ERD) or * daratumumab/bortezomib/dexamethasone DVD) or * daratumumab/lenalidomide/dexamethasone (DRD) or * ixazomib/lenalidomide/dexamethasone (IRD) or * pomalidomide/bortezomib/dexamethasone (PVD) or * carfilzomib/daratumumab/dexamethasone (KDD) or * daratumumab/pomalidomide/dexamethasone (DPD) or * isatuximab/carfilzomib/dexamethasone (Isa-KD) or * selinexor/bortezomib/dexamethasone (SVD) Alternatively, autologous stem cell transplantation may also be performed, if sufficient stem cells are still cryopreserved.

Primary Outcome Measure

Overall survival at five years after randomization [ Time Frame: at 5 years after randomization ]

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