Multiple MyelomaPhase 3AlloRelapseMMNCT05675319
Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy
A Phase 3 study testing Allogeneic Stem Cells, carfilzomib/lenalidomide/dexamethasone (KRD) and elotuzumab/lenalidomide/dexamethasone (ERD) in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 30 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Allogeneic Stem Cells, carfilzomib/lenalidomide/dexamethasone (KRD) and elotuzumab/lenalidomide/dexamethasone (ERD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 30 sitesGermany
- Study dates
- 3 Mar 2023to 21 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:
- Multiple Myeloma
- Age 18 - 65 years
- A signed informed consent form must be obtained before participation in the study
- Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
- 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
Show all 10Show fewer
- Negative pregnancy test in female patients
- Maximum of 1 cycle salvage therapy prior to study inclusion
- 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
- CR/PR or SD according to IMWG-criteria after 3 cycles salvage therapy within the study
Who cannot join
- 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:
- 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
- Active hepatitis B or C infection or uncontrolled HIV infection
- Other, active malignant disease
- Prior treatment with allogeneic stem cells
Show all 9Show fewer
- 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
- Positive serum pregnancy test at screening and before first treatment or breastfeeding
- PD under salvage therapy
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Germany30 sites
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
University Hospital Augsburg
Augsburg, Bavaria, 86156
Charité - University of Medicine Berlin
Berlin, State of Berlin, 10117
Helios Hospital Berlin-Buch
Berlin, State of Berlin, 13125
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Hospital of Chemnitz gGmbH
Chemnitz, Saxony, 09116
University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
University Hospital Frankfurt/ Main
Frankfurt am Main, Hesse, 60590
University Hospital of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, 06120
Asklepios Hospital Hamburg St. Georg
Hamburg, Free and Hanseatic City of Hamburg, 20099
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
University Hospital Jena
Jena, Thuringia, 07743
University Hospital of Schleswig-Holstein (Campus Kiel)
Kiel, Schleswig-Holstein, 24105
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131
Philipps University Marburg
Marburg, Hesse, 35037
University Hospital Munich ( LMU)
München, Bavaria, 80336
University Hospital of the Technical University Munich rechts der Isar
München, Bavaria, 81675
University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Hospital North Nürnberg
Nuremberg, Bavaria, 90419
Hospital Oldenburg (AöR)
Oldenburg, Oldenburg, 26133
University Hospital Regensburg
Regensburg, Bavaria, 93053
Robert-Bosch Hospital Stuttgart
Stuttgart, Baden-Wurttemberg, 70376
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
University Hospital of Ulm
Ulm, Baden-Wurttemberg, 89081
University Hospital of Würzburg
Würzburg, Bavaria, 97070
About this study
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.
Read the detailed 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.
- Conditions
- Multiple Myeloma
- Being tested
- Allogeneic Stem Cells, carfilzomib/lenalidomide/dexamethasone (KRD), elotuzumab/lenalidomide/dexamethasone (ERD), daratumumab/bortezomib/dexamethasone (DVD), daratumumab/lenalidomide/dexamethasone (DRD)
- Keywords
- first relapse/progression after first-line therapy, allogeneic stem cell transplantation, salvage therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Stem CellsDrug
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 CellsDrug
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 group | Role | What they receive |
|---|---|---|
| Arm A (allo SCT) | Experimental | Allogeneic stem cell transplantation Receives: Drug: Allogeneic Stem Cells |
| Arm B (conventional therapy) | Active comparator | 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. Receives: Drug: carfilzomib/lenalidomide/dexamethasone (KRD); Drug: elotuzumab/lenalidomide/dexamethasone (ERD); Drug: daratumumab/bortezomib/dexamethasone (DVD); Drug: daratumumab/lenalidomide/dexamethasone (DRD); Drug: ixazomib/lenalidomide/dexamethasone (IRD); Drug: pomalidomide/bortezomib/dexamethasone (PVD); Drug: carfilzomib/daratumumab/dexamethasone (KDD); Drug: Autologous Stem Cells; Drug: daratumumab/pomalidomide/dexamethasone (DPD); Drug: isatuximab/carfilzomib/dexamethasone (Isa-KD); Drug: selinexor/bortezomib/dexamethasone (SVD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at five years after randomization
The present clinical study aims to demonstrate the superiority of allogeneic stem cell transplantation compared to conventional therapy for the difference in overall survival at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell therapy.
Measured: at 5 years after randomization
Secondary outcomes (19)
Event-free survival at 1 year after randomization
A secondary objective is to show an improvement of progress free survival and relapse free survival after allogeneic stem cell transplantation compared to conventional therapy.
Events are defined as:
- Progression or
- Relapse or
- Engraftment Failure or
- Death of any cause
Measured: from randomization to 1 year after randomization
Event-free survival at 3 years after randomization
A further secondary objective is to show an improvement of progress free survival and relapse free survival after allogeneic stem cell transplantation compared to conventional therapy.
Events are defined as:
- Progression or
- Relapse or
- Engraftment Failure or
- Death of any cause
Measured: from randomization to 3 years after randomization
Event-free survival at 5 years after randomization
A secondary objective is to show an improvement of progress free survival and relapse free survival after allogeneic stem cell transplantation compared to conventional therapy.
Events are defined as:
- Progression or
- Relapse or
- Engraftment Failure or
- Death of any cause
Measured: from randomization to 5 years after randomization
Change from baseline in total EORTC score at 1 year after randomization
The aim of the quality of life questionnaires (QLQ) is to provide a comparison between the two treatment arms. Quality of life according EORTC (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) \& Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)) will be assessed in both groups..
A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology/ sickness. Patients will be observed from baseline until database lock for final analysis and adjusted mean calculated at 1 year after randomization.
Measured: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months and 12 months after randomization
Change from baseline in total EORTC score at 3 years after randomization
The aim of the quality of life questionnaires (QLQ) is to provide a comparison between the two treatment arms. Quality of life according EORTC (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) \& Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)) will be assessed in both groups.
A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology/ sickness. Patients will be observed from baseline until database lock for final analysis and adjusted mean calculated at 3 years after randomization.
Measured: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months, 1 year, 2 years and 3 years after randomization
Change from baseline in total EORTC score at 5 years after randomization
The aim of the quality of life questionnaires (QLQ) is to provide a comparison between the two treatment arms. Quality of life according EORTC (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) \& Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)) will be assessed in both groups.
A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology/ sickness. Patients will be observed from baseline until database lock for final analysis and adjusted mean calculated at 5 years after randomization.
Measured: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months, 1, 2, 3, 4 and 5 years after randomization
Time to first occurrence of remission after randomization
Patients will be followed from randomization until database lock for final analysis and cumulative incidence of first remission (partial or complete), at 2 years after randomization, is reported.
Measured: at 30 days, 100 days, 6 months, 1 and 2 years after randomization
Non-relapse mortality (NRM) at 1 year after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 1 year after randomization was reported.
Measured: from randomization to 1 year after randomization, an average of 1 year
Non-relapse mortality (NRM) at 3 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 3 years after randomization was reported.
Measured: from randomization to 3 years after randomization, an average of 3 years
Non-relapse mortality (NRM) at 5 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 5 years after randomization was reported.
Measured: from randomization to 5 years after randomization, an average of 5 years
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 1 year after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any acute Graft-versus-Host Disease (GvHD, according to Przepiorka et al.) at 1 year after randomization is reported
Measured: at 30 days, 100 days, 6 months and 1 year after randomization, an average of 1 year
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 3 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD (according to Przepiorka et al.) at 3 years after randomization is reported
Measured: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months and 3 years after randomization, an average of 3 years
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 5 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD (according to Przepiorka et al.) at 5 years after randomization is repoted.
Measured: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months, 3, 4 and 5 years after randomization, an average of 5 years
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 1 year after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD (according to Jagasia et al.) at 1 year after randomization is reported.
Measured: at 30 days, 100 days, 6 months and 1 year after randomization, an average of 1 year
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 3 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD (according to Jagasia et al.) at 3 years after randomization is reported.
Measured: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months and 3 years after randomization, an average of 3 years
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 5 years after randomization
Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD (according to Jagasia et al.) at 5 years after randomization is reported.
Measured: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months, 3, 4 and 5 years after randomization, an average of 5 years
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 1 year after randomization
The severity and/or intensity of an adverse event will be graded based upon the patient's symptoms according to the current active version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 1 year after randomization is reported.
Measured: from randomization to 1 year after randomization, an average of 1 year
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 3 years after randomization
The severity and/or intensity of an adverse event will be graded based upon the patient's symptoms according to the current active version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 3 years after randomization is reported.
Measured: from randomization to 3 years after randomization, an average of 3 years
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 5 years after randomization
The severity and/or intensity of an adverse event will be graded based upon the patient's symptoms according to the current active version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Patients will be observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 5 years after randomization is reported.
Measured: from randomization to 5 years after randomization, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start3 Mar 2023
- Primary completion14 Mar 2025
- Study completion21 Mar 2025
Why it stopped: The reason for the end of recruitment is that the recruitment target could not be achieved despite all efforts and the G-BA (financing party) does not consider a continuation of the AlloRelapseMM study to be expedient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, Staburo GmbH
- Responsible party
- Sponsor
- Investigators
- Francis Ayuk, Prof. Dr. med., Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675319
- Sponsor's protocol ID
- AlloRelapseMMStudy
- Acronym
- AlloRelapseMM
- Status last verified
- Dec 2025
- First submitted
- 6 Nov 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39865222
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy
- ClinicalTrials.gov ID
- NCT05675319
- Acronym / sponsor ID
- AlloRelapseMM / AlloRelapseMMStudy
- Conditions
- Multiple Myeloma
- Keywords
- first relapse/progression after first-line therapy, allogeneic stem cell transplantation, salvage therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reason for the end of recruitment is that the recruitment target could not be achieved despite all efforts and the G-BA (financing party) does not consider a continuation of the AlloRelapseMM study to be expedient.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, Staburo GmbH
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (allo SCT) | Experimental | Drug: Allogeneic Stem CellsAllogeneic stem cell transplantation |
| Arm B (conventional therapy) | Active comparator | Drug: carfilzomib/lenalidomide/dexamethasone (KRD), Drug: elotuzumab/lenalidomide/dexamethasone (ERD), Drug: daratumumab/bortezomib/dexamethasone (DVD), Drug: daratumumab/lenalidomide/dexamethasone (DRD), Drug: ixazomib/lenalidomide/dexamethasone (IRD), Drug: pomalidomide/bortezomib/dexamethasone (PVD), Drug: carfilzomib/daratumumab/dexamethasone (KDD), Drug: Autologous Stem Cells, Drug: daratumumab/pomalidomide/dexamethasone (DPD), Drug: isatuximab/carfilzomib/dexamethasone (Isa-KD), Drug: selinexor/bortezomib/dexamethasone (SVD)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:
- Multiple Myeloma
- Age 18 - 65 years
- A signed informed consent form must be obtained before participation in the study
- Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
Key exclusion criteria (9 listed)
- 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:
- 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
- Active hepatitis B or C infection or uncontrolled HIV infection
- Other, active malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Stem CellsAllogeneic Stem Cell Transplantation | Drug | Arm A (allo SCT) |
| carfilzomib/lenalidomide/dexamethasone (KRD)triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version | Drug | Arm B (conventional therapy) |
| elotuzumab/lenalidomide/dexamethasone (ERD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| daratumumab/bortezomib/dexamethasone (DVD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| daratumumab/lenalidomide/dexamethasone (DRD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| ixazomib/lenalidomide/dexamethasone (IRD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| pomalidomide/bortezomib/dexamethasone (PVD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| carfilzomib/daratumumab/dexamethasone (KDD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| Autologous Stem CellsAutologous Stem Cell Transplantation | Drug | Arm B (conventional therapy) |
| daratumumab/pomalidomide/dexamethasone (DPD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| isatuximab/carfilzomib/dexamethasone (Isa-KD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
| selinexor/bortezomib/dexamethasone (SVD)triple regimen for first relapse should be applied according to latest SmPC version | Drug | Arm B (conventional therapy) |
Primary outcome
Overall survival at five years after randomization
Time frame: at 5 years after randomization
The present clinical study aims to demonstrate the superiority of allogeneic stem cell transplantation compared to conventional therapy for the difference in overall survival at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell therapy.
19 secondary outcomes
Event-free survival at 1 year after randomization
Time frame: from randomization to 1 year after randomization
Event-free survival at 3 years after randomization
Time frame: from randomization to 3 years after randomization
Event-free survival at 5 years after randomization
Time frame: from randomization to 5 years after randomization
Change from baseline in total EORTC score at 1 year after randomization
Time frame: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months and 12 months after randomization
Change from baseline in total EORTC score at 3 years after randomization
Time frame: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months, 1 year, 2 years and 3 years after randomization
Change from baseline in total EORTC score at 5 years after randomization
Time frame: at visit Screening, at the end of cycle 3 (84 days, each cycle is 28 days) of salvage therapy, 6 months, 1, 2, 3, 4 and 5 years after randomization
Time to first occurrence of remission after randomization
Time frame: at 30 days, 100 days, 6 months, 1 and 2 years after randomization
Non-relapse mortality (NRM) at 1 year after randomization
Time frame: from randomization to 1 year after randomization, an average of 1 year
Non-relapse mortality (NRM) at 3 years after randomization
Time frame: from randomization to 3 years after randomization, an average of 3 years
Non-relapse mortality (NRM) at 5 years after randomization
Time frame: from randomization to 5 years after randomization, an average of 5 years
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 1 year after randomization
Time frame: at 30 days, 100 days, 6 months and 1 year after randomization, an average of 1 year
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 3 years after randomization
Time frame: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months and 3 years after randomization, an average of 3 years
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 5 years after randomization
Time frame: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months, 3, 4 and 5 years after randomization, an average of 5 years
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 1 year after randomization
Time frame: at 30 days, 100 days, 6 months and 1 year after randomization, an average of 1 year
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 3 years after randomization
Time frame: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months and 3 years after randomization, an average of 3 years
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 5 years after randomization
Time frame: at 30 days, 100 days, 6 months, 1 year, 18 months and 2 years, 30 months, 3, 4 and 5 years after randomization, an average of 5 years
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 1 year after randomization
Time frame: from randomization to 1 year after randomization, an average of 1 year
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 3 years after randomization
Time frame: from randomization to 3 years after randomization, an average of 3 years
Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 5 years after randomization
Time frame: from randomization to 5 years after randomization, an average of 5 years
Results and safety
The study was stopped early (reason given: The reason for the end of recruitment is that the recruitment target could not be achieved despite all efforts and the G-BA (financing party) does not consider a continuation of the AlloRelapseMM study to be expedient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Derived from this study: PubMed 39865222Glockner 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Ayuk, Prof. Dr. med. principal investigator
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allogeneic Stem Cells, carfilzomib/lenalidomide/dexamethasone (KRD) and elotuzumab/lenalidomide/dexamethasone (ERD) in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 30 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The reason for the end of recruitment is that the recruitment target could not be achieved despite all efforts and the G-BA (financing party) does not consider a continuation of the AlloRelapseMM study to be expedient.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at five years after randomization (time frame: at 5 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.