A Phase 3 interventional study of Allogeneic Stem Cells and carfilzomib/lenalidomide/dexamethasone (KRD) in Multiple Myeloma, sponsored by Universitätsklinikum Hamburg-Eppendorf. Terminated at 30 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 3, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 28 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:
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:
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
Allogeneic stem cell transplantation
Drug: Allogeneic Stem Cells
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.
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)
Allogeneic Stem Cell Transplantation
triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
Autologous Stem Cell Transplantation
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
triple regimen for first relapse should be applied according to latest SmPC version
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.
Time frame: at 5 years after randomization
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
Time frame: 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
Time frame: 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
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
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
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
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: from randomization to 5 years after randomization, an average of 5 years
Event-free survival at 3 and 5 years after randomization
Patients will be observed from randomization until database lock for interim analysis and the event-free survival (EFS) rate is calculated at 3 and 5 years after randomization. Events are defined as: * Progression or * Relapse or * Engraftment Failure or * Death of any cause
Time frame: from randomization to 3 and 5 years after randomization
Change from baseline in total EORTC score (Summary Score) at 3 and 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 interim analysis and adjusted mean is calculated at 3 and 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, an average at 3 and 5 years after randomization
Non-relapse mortality at 1, 3 and 5 years after randomization
Patients will be observed from randomization until database lock for interim analysis and cumulative incidence of death before any relapse at 1, 3 and 5 years after randomization is reported
Time frame: from randomization to 1, 3 and 5 years after randomization, an average of 1, 3 and 5 years
Cumulative incidence of acute GvHD after allogeneic stem cell transplantation at 1, 3 and 5 years after randomization
Patients will be observed from randomization until database lock for interim analysis and cumulative incidence of any acute GvHD (according to Przepiorka et al.) at 1, 3 and 5 years after randomization is reported
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 1, 3 and 5 years
Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation at 1, 3 and 5 years after randomization
Patients will be observed from randomization until database lock for interim analysis and cumulative incidence of any chronic GvHD (according to Jagasia et al.) at 1, 3 and 5 years after randomization is reported
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 1, 3 and 5 years
Time to first occurrence of Minimal Residual Disease (MRD)
Patient observed from randomization until database lock for interim analysis and until database lock for final and rate of occurrence calculated at 6 months, 1 year and 2 years after randomization
Time frame: at 30 days, 100 days, 6 months, 1 and 2 years after randomization, rate of occurence at 6 months, 1 and 2 years after randomization
Time to first occurrence of progression
Patients will be observed from randomization until database lock for interim analysis and rates at 3 and 5 years after randomization are calculated; and patients will be observed from randomization until database lock for final analysis and rates at 1, 3, and 5 years after randomization are calculated
Time frame: from randomization to 1, 3, and 5 years after randomization
Time to first recurrence of relapse
Patients will be followed from randomization to database lock for interim analysis and rates at 3 and 5 years after randomization are calculated; and patients will be followed from randomization to database lock for final analysis and rates at 1, 3, and 5 years after randomization are calculated.
Time frame: at 1, 3, and 5 years after randomization
Time to first occurrence of graft failure after stem cell transplatation
Patients are followed from randomization until database lock for interim analysis and rates at 3 and 5 years post-randomization are calculated; and patients are followed from randomization until database lock for final analysis and rates at 1, 3, and 5 years post-randomization are calculated. A graft failure is defined as no stable neutrophil count \> 0.5 x 10\^9/l at day 28 post-SCT.
Time frame: at day 30 after after randomization
Plan to share: No
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Universitätsklinikum Hamburg-Eppendorf