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

Last updated: April 16, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Terminated

Phase

3

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Bone Neoplasm

Treatment

carfilzomib/daratumumab/dexamethasone (KDD)

ixazomib/lenalidomide/dexamethasone (IRD)

carfilzomib/lenalidomide/dexamethasone (KRD)

Clinical Study ID

NCT05675319
AlloRelapseMMStudy
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:

  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 ortwice and maintenance therapy), Additionally: meeting the need for treatment basedon 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 MUDor 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 thestudy

Exclusion

Exclusion Criteria:

Patients are excluded from the study if any one of criteria 1-6 are met at registration and if criterion 7 is met before randomization:

  1. Non-sufficient organ function defined as: Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥3 higher thannormal values Cardiac ejection fraction ≤ 50% GFR < 30 ml/min DLCO < 35 % orcontinuous 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 thehalf-life of the IMP, whichever is longer, prior to registration

  6. Positive serum pregnancy test at screening and before first treatment orbreastfeeding

  7. PD under salvage therapy

Study Design

Total Participants: 28
Treatment Group(s): 12
Primary Treatment: carfilzomib/daratumumab/dexamethasone (KDD)
Phase: 3
Study Start date:
March 03, 2023
Estimated Completion Date:
March 21, 2025

Study Description

The primary objective of the present clinical study aims to demonstrate the superiority of allogeneic stem cell transplantation (allo SCT) compared to conventional therapy for the difference in overall survival (OS) at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell therapy.

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.

Connect with a study center

  • University Hospital of Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • University Hospital Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Robert-Bosch Hospital Stuttgart

    Stuttgart, Baden-Württemberg 70376
    Germany

    Site Not Available

  • University Hospital Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • University Hospital of Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • University Hospital Augsburg

    Augsburg, Bayern 86156
    Germany

    Site Not Available

  • Munich Hospital Schwabing

    München, Bayern 80804
    Germany

    Site Not Available

  • University Hospital Munich ( LMU)

    München, Bayern 80336
    Germany

    Site Not Available

  • University Hospital of the Technical University Munich rechts der Isar

    München, Bayern 81675
    Germany

    Site Not Available

  • Hospital North Nürnberg

    Nürnberg, Bayern 90419
    Germany

    Site Not Available

  • University Hospital Regensburg

    Regensburg, Bayern 93053
    Germany

    Site Not Available

  • University Hospital of Würzburg

    Würzburg, Bayern 97070
    Germany

    Site Not Available

  • University Hospital Frankfurt/ Main

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Philipps University Marburg

    Marburg, Hessen 35037
    Germany

    Site Not Available

  • University Medical Center Göttingen

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • University Hospital RWTH Aachen

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Site Not Available

  • University Hospital Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • University Hospital Düsseldorf

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • University Hospital Essen

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • University Hospital Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • University Medical Center Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Hospital of Chemnitz gGmbH

    Chemnitz, Sachsen 09116
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • University Hospital of Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • University Hospital Halle (Saale)

    Halle (Saale), Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • University Hospital of Schleswig-Holstein (Campus Kiel)

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • University Hospital Jena

    Jena, Thüringen 07743
    Germany

    Site Not Available

  • Charité - University of Medicine Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Helios Hospital Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Asklepios Hospital Hamburg St. Georg

    Hamburg, 20099
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Hospital Oldenburg (AöR)

    Oldenburg, 26133
    Germany

    Site Not Available

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