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Stem cell transplant vs. standard care in myeloma relapse: a Head-to-Head trial

NCT ID NCT05675319

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a donor stem cell transplant (allogeneic) works better than standard drug therapy for people with multiple myeloma that came back after initial treatment. It included adults aged 18-70 with a compatible donor. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

28 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: 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 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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Asklepios Hospital Hamburg St. Georg

    Hamburg, Free and Hanseatic City of Hamburg, 20099, Germany

  • Charité - University of Medicine Berlin

    Berlin, State of Berlin, 10117, Germany

  • Helios Hospital Berlin-Buch

    Berlin, State of Berlin, 13125, Germany

  • Hospital North Nürnberg

    Nuremberg, Bavaria, 90419, Germany

  • Hospital Oldenburg (AöR)

    Oldenburg, Oldenburg, 26133, Germany

  • Hospital of Chemnitz gGmbH

    Chemnitz, Saxony, 09116, Germany

  • Philipps University Marburg

    Marburg, Hesse, 35037, Germany

  • Robert-Bosch Hospital Stuttgart

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • University Hospital Augsburg

    Augsburg, Bavaria, 86156, Germany

  • University Hospital Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • University Hospital Carl Gustav Carus

    Dresden, Saxony, 01307, Germany

  • University Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • University Hospital Frankfurt/ Main

    Frankfurt am Main, Hesse, 60590, Germany

  • University Hospital Halle (Saale)

    Halle, Saxony-Anhalt, 06120, Germany

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • University Hospital Jena

    Jena, Thuringia, 07743, Germany

  • University Hospital Munich ( LMU)

    München, Bavaria, 80336, Germany

  • University Hospital Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Hospital RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

  • University Hospital Regensburg

    Regensburg, Bavaria, 93053, Germany

  • University Hospital Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Hospital of Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Hospital of Schleswig-Holstein (Campus Kiel)

    Kiel, Schleswig-Holstein, 24105, Germany

  • University Hospital of Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Hospital of Würzburg

    Würzburg, Bavaria, 97070, Germany

  • University Hospital of the Technical University Munich rechts der Isar

    München, Bavaria, 81675, Germany

  • University Medical Center Göttingen

    Göttingen, Lower Saxony, 37075, Germany

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • University Medical Center Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

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