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

Summary

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.

Conditions

• Multiple Myeloma

Interventions

DRUG

Allogeneic Stem Cells

Allogeneic Stem Cell Transplantation

DRUG

carfilzomib/lenalidomide/dexamethasone (KRD)

triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version

DRUG

elotuzumab/lenalidomide/dexamethasone (ERD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

daratumumab/bortezomib/dexamethasone (DVD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

daratumumab/lenalidomide/dexamethasone (DRD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

ixazomib/lenalidomide/dexamethasone (IRD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

pomalidomide/bortezomib/dexamethasone (PVD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

carfilzomib/daratumumab/dexamethasone (KDD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

Autologous Stem Cells

Autologous Stem Cell Transplantation

DRUG

daratumumab/pomalidomide/dexamethasone (DPD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

isatuximab/carfilzomib/dexamethasone (Isa-KD)

triple regimen for first relapse should be applied according to latest SmPC version

DRUG

selinexor/bortezomib/dexamethasone (SVD)

triple regimen for first relapse should be applied according to latest SmPC version

Sponsors & Collaborators

• Gemeinsamer Bundesausschuss (G-BA)

  collaborator UNKNOWN

• Staburo GmbH

  collaborator INDUSTRY

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Francis Ayuk, Prof. Dr. med. · University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-03

Primary Completion

2025-03-14

Completion

2025-03-21

Countries

• Germany

Study Locations