Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy
NCT ID: NCT05675319
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
28 participants
INTERVENTIONAL
2023-03-03
2025-03-21
Brief Summary
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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.
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Detailed Description
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The secondary objectives are to show an improvement of progression free survival and relapse free survival after allo SCT compared to conventional therapy.
In addition, quality of life, toxicities, recurrence rates, non-relapse mortality (NRM), remission rates including minimal residual disease (MRD) and incidence of severe or life-threatening infection between the two arms are compared. Acute and chronic graft-versus-host disease (GvHD) after allo SCT are evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (allo SCT)
Allogeneic stem cell transplantation
Allogeneic Stem Cells
Allogeneic Stem Cell Transplantation
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.
carfilzomib/lenalidomide/dexamethasone (KRD)
triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version
elotuzumab/lenalidomide/dexamethasone (ERD)
triple regimen for first relapse should be applied according to latest SmPC version
daratumumab/bortezomib/dexamethasone (DVD)
triple regimen for first relapse should be applied according to latest SmPC version
daratumumab/lenalidomide/dexamethasone (DRD)
triple regimen for first relapse should be applied according to latest SmPC version
ixazomib/lenalidomide/dexamethasone (IRD)
triple regimen for first relapse should be applied according to latest SmPC version
pomalidomide/bortezomib/dexamethasone (PVD)
triple regimen for first relapse should be applied according to latest SmPC version
carfilzomib/daratumumab/dexamethasone (KDD)
triple regimen for first relapse should be applied according to latest SmPC version
Autologous Stem Cells
Autologous Stem Cell Transplantation
daratumumab/pomalidomide/dexamethasone (DPD)
triple regimen for first relapse should be applied according to latest SmPC version
isatuximab/carfilzomib/dexamethasone (Isa-KD)
triple regimen for first relapse should be applied according to latest SmPC version
selinexor/bortezomib/dexamethasone (SVD)
triple regimen for first relapse should be applied according to latest SmPC version
Interventions
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Allogeneic Stem Cells
Allogeneic Stem Cell Transplantation
carfilzomib/lenalidomide/dexamethasone (KRD)
triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version
elotuzumab/lenalidomide/dexamethasone (ERD)
triple regimen for first relapse should be applied according to latest SmPC version
daratumumab/bortezomib/dexamethasone (DVD)
triple regimen for first relapse should be applied according to latest SmPC version
daratumumab/lenalidomide/dexamethasone (DRD)
triple regimen for first relapse should be applied according to latest SmPC version
ixazomib/lenalidomide/dexamethasone (IRD)
triple regimen for first relapse should be applied according to latest SmPC version
pomalidomide/bortezomib/dexamethasone (PVD)
triple regimen for first relapse should be applied according to latest SmPC version
carfilzomib/daratumumab/dexamethasone (KDD)
triple regimen for first relapse should be applied according to latest SmPC version
Autologous Stem Cells
Autologous Stem Cell Transplantation
daratumumab/pomalidomide/dexamethasone (DPD)
triple regimen for first relapse should be applied according to latest SmPC version
isatuximab/carfilzomib/dexamethasone (Isa-KD)
triple regimen for first relapse should be applied according to latest SmPC version
selinexor/bortezomib/dexamethasone (SVD)
triple regimen for first relapse should be applied according to latest SmPC version
Eligibility Criteria
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Inclusion Criteria
1. Multiple Myeloma
2. Age 18 - 65 years
3. A signed informed consent form must be obtained before participation in the study
4. Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
5. 1st relapse/ progression according to IMWG criteria after first-line therapy (consisting of induction therapy followed by autologous transplantation once or twice and maintenance therapy), Additionally: meeting the need for treatment based on the SLiM-CRAB-criteria
6. Negative pregnancy test in female patients
7. Maximum of 1 cycle salvage therapy prior to study inclusion
8. Availability of a fully compatible stem cell donor (HLA-ident. Sibling or 10/10 MUD or 9/10 MMUD if mismatch affects DQB) after 3 cycles salvage therapy
9. CR/PR or SD according to IMWG-criteria after 3 cycles salvage therapy within the study
Exclusion Criteria
1. Non-sufficient organ function defined as:
Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥3 higher than normal values Cardiac ejection fraction ≤ 50% GFR \< 30 ml/min DLCO \< 35 % or continuous oxygen dependency
2. Active hepatitis B or C infection or uncontrolled HIV infection
3. Other, active malignant disease
4. Prior treatment with allogeneic stem cells
5. Participation in a clinical trial or taking an IMP within 30 days or five times the half-life of the IMP, whichever is longer, prior to registration
6. Positive serum pregnancy test at screening and before first treatment or breastfeeding
7. PD under salvage therapy
18 Years
70 Years
ALL
No
Sponsors
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Gemeinsamer Bundesausschuss (G-BA)
UNKNOWN
Staburo GmbH
INDUSTRY
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Francis Ayuk, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
Locations
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University Hospital of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Robert-Bosch Hospital Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
University Hospital of Ulm
Ulm, Baden-Wurttemberg, Germany
University Hospital Augsburg
Augsburg, Bavaria, Germany
University Hospital Munich ( LMU)
München, Bavaria, Germany
University Hospital of the Technical University Munich rechts der Isar
München, Bavaria, Germany
Hospital North Nürnberg
Nuremberg, Bavaria, Germany
University Hospital Regensburg
Regensburg, Bavaria, Germany
University Hospital of Würzburg
Würzburg, Bavaria, Germany
Asklepios Hospital Hamburg St. Georg
Hamburg, Hamburg, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
University Hospital Frankfurt/ Main
Frankfurt am Main, Hesse, Germany
Philipps University Marburg
Marburg, Hesse, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
University Hospital Münster
Münster, North Rhine-Westphalia, Germany
Hospital Oldenburg (AöR)
Oldenburg, Oldenburg, Germany
University Medical Center Mainz
Mainz, Rhineland-Palatinate, Germany
Hospital of Chemnitz gGmbH
Chemnitz, Saxony, Germany
University Hospital Carl Gustav Carus
Dresden, Saxony, Germany
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, Germany
University Hospital of Schleswig-Holstein (Campus Kiel)
Kiel, Schleswig-Holstein, Germany
Charité - University of Medicine Berlin
Berlin, State of Berlin, Germany
Helios Hospital Berlin-Buch
Berlin, State of Berlin, Germany
University Hospital Jena
Jena, Thuringia, Germany
Countries
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References
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Glockner A, Schonland S, Einsele H, Kroger N. Rationale and design of the multicenter, national, randomized, open labeled phase III trial: allogeneic stem cell transplantation as a potential curative treatment for patients with relapsed or progressed multiple myeloma (AlloRelapseMM Study). BMC Cancer. 2025 Jan 27;25(1):147. doi: 10.1186/s12885-025-13503-7.
Related Links
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Other Identifiers
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AlloRelapseMMStudy
Identifier Type: -
Identifier Source: org_study_id
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