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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Allogeneic Stem Cells; 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

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 Type: Interventional
• Enrollment (Anticipated): 482
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicolaus Kröger, Prof. Dr.; Phone Number: +4940741054851; Email: n.kroeger@uke.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Charité - University of Medicine Berlin
    • Contact: Igor-Wolfgang Blau, Prof. Dr.
    • Principal Investigator: Igor-Wolfgang Blau, Prof. Dr.
    • Sub-Investigator: Giang Lam Vuong, Dr.
  • Berlin, Germany, 13125
    • Recruiting
    • HELIOS Hospital Berlin-Buch
    • Contact: Judith Niederland, Dr.
    • Principal Investigator: Judith Niederland, Dr.
    • Sub-Investigator: Pearl van Heteren, Dr.
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Principal Investigator: Nicolaus Kröger, Prof. Dr.
  • Hamburg, Germany, 20099
    • Not yet recruiting
    • Asklepios Hospital Hamburg St. Georg
    • Contact: Ahmet Elmaagacli, Prof. Dr.
    • Principal Investigator: Ahmet Elmaagacli, Prof. Dr.
    • Sub-Investigator: Hans Salwender, Dr.
  • Oldenburg, Germany, 26133
    • Not yet recruiting
    • Hospital Oldenburg (AöR)
    • Contact: Christoph Kimmich, Dr.
    • Principal Investigator: Christoph Kimmich, Dr.
    • Sub-Investigator: Jochen Casper, Prof. Dr.
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Not yet recruiting
      • University Hospital of Freiburg
      • Principal Investigator: Ralph Wäsch, Prof. Dr.
      • Sub-Investigator: Monika Engelhardt, Prof. Dr.
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Not yet recruiting
      • University Hospital Heidelberg
      • Contact: Stefan Schönland, Prof. Dr.
      • Principal Investigator: Stefan Schönland, Prof. Dr.
      • Sub-Investigator: Ute Hegenbart, Prof. Dr.
    • Stuttgart, Baden-Württemberg, Germany, 70376
      • Recruiting
      • Robert-Bosch Hospital Stuttgart
      • Principal Investigator: Martin Kaufmann, Dr.
      • Sub-Investigator: Sonja Martin, Dr.
      • Contact: Martin Kaufmann, Dr.
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Not yet recruiting
      • University Hospital Tübingen
      • Contact: Wolfgang Bethge, Prof. Dr.
      • Sub-Investigator: Christoph Faul, Dr.
      • Sub-Investigator: Britta Besemer, Dr.
    • Ulm, Baden-Württemberg, Germany, 89081
      • Not yet recruiting
      • University Hospital of Ulm
      • Contact: Elisa Sala, Dr.
      • Principal Investigator: Elisa Sala, Dr.
      • Sub-Investigator: Miriam Knull, Dr.
  • Bayern
    • Augsburg, Bayern, Germany, 86156
      • Recruiting
      • University Hospital Augsburg
      • Principal Investigator: Christoph Schmid, Prof. Dr.
      • Contact: Christoph Schmid, Pof. Dr.
      • Sub-Investigator: Tim Pfeiffer, Dr.
    • München, Bayern, Germany, 80336
      • Not yet recruiting
      • University Hospital Munich ( LMU)
      • Contact: Johanna Tischer, PD Dr.
      • Principal Investigator: Johanna Tischer, PD Dr.
      • Sub-Investigator: Sebastian Theurich, Prof. Dr.
    • München, Bayern, Germany, 80804
      • Not yet recruiting
      • Munich Hospital Schwabing
      • Contact: Andreas Hausmann, Dr.
      • Principal Investigator: Andreas Hausmann, Dr.
      • Sub-Investigator: Nadine Anstötz, Dr.
    • München, Bayern, Germany, 81675
      • Not yet recruiting
      • University Hospital of the Technical University Munich rechts der Isar
      • Contact: Mareike Verbeek, Dr.
      • Principal Investigator: Mareike Verbeek, Dr.
      • Sub-Investigator: Peter Herhaus, Dr.
    • Nürnberg, Bayern, Germany, 90419
      • Not yet recruiting
      • Hospital North Nürnberg
      • Principal Investigator: Kerstin Schäfer-Eckart, Dr.
      • Sub-Investigator: Knut Wendelin, Dr.
    • Regensburg, Bayern, Germany, 93053
      • Not yet recruiting
      • University Hospital Regensburg
      • Contact: Matthias Edinger, Prof. Dr.
    • Würzburg, Bayern, Germany, 97070
      • Recruiting
      • University Hospital of Würzburg
      • Contact: Sabrina Kraus, Dr.
      • Principal Investigator: Sabrina Kraus, Dr.
      • Sub-Investigator: Jochen Frietsch, Dr.
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Recruiting
      • University Hospital Frankfurt/ Main
      • Contact: Ivana von Metzler, Dr.
      • Principal Investigator: Ivana von Metzler, Dr.
      • Sub-Investigator: Fabian Lang, Dr.
    • Marburg, Hessen, Germany, 35037
      • Recruiting
      • Philipps University Marburg
      • Contact: Andreas Burchert, Prof. Dr.
      • Principal Investigator: Andreas Burchert, Prof. Dr.
      • Sub-Investigator: Kristina Sohlbach, Dr.
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • Not yet recruiting
      • University Medical Center Göttingen
      • Principal Investigator: Wolfram Jung, Dr.
      • Sub-Investigator: Justin Hasenkamp, Dr.
      • Contact: Wolfram Jung, Dr.
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Not yet recruiting
      • University Hospital RWTH Aachen
      • Contact: Edgar Jost, PD Dr.
      • Principal Investigator: Edgar Jost, PD Dr.
      • Sub-Investigator: Deniz Gezer, Dr.
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Recruiting
      • University Hospital Bonn
      • Contact: Tobias Holderried, Dr.
      • Principal Investigator: Tobias Holderried, Dr.
      • Sub-Investigator: Martin Schumacher, Dr.
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Not yet recruiting
      • University Hospital Düsseldorf
      • Contact: Guido Kobbe, Prof. Dr.
      • Sub-Investigator: Roland Fenk, Prof. Dr.
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Not yet recruiting
      • University Hospital Essen
      • Contact: Rudolf Trenschel, Dr.
      • Principal Investigator: Rudolf Trenschel, Dr.
      • Sub-Investigator: Thomas Schroeder, PD Dr.
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Not yet recruiting
      • University Hospital Münster
      • Contact: Matthias Stelljes, Prof. Dr.
      • Sub-Investigator: Evgenii Shumilov, Dr.
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Not yet recruiting
      • University Medical Center Mainz
      • Contact: Eva Maria Wagner-Drouet, Dr.
      • Principal Investigator: Eva Maria Wagner-Douret, Dr.
      • Sub-Investigator: Markus Munder, Prof. Dr.
      • Sub-Investigator: Beate Hauptrock, Dr.
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Recruiting
      • Hospital of Chemnitz gGmbH
      • Principal Investigator: Mathias Hänel, PD Dr.
      • Sub-Investigator: Anke Morgner, Dr.
    • Dresden, Sachsen, Germany, 01307
      • Recruiting
      • University Hospital Carl Gustav Carus
      • Contact: Raphael Teipel, Dr.
      • Principal Investigator: Raphael Teipel, Dr.
      • Sub-Investigator: Karolin Trautmann-Grill, Dr.
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • Not yet recruiting
      • University Hospital Halle (Saale)
      • Contact: Lutz Müller, PD Dr.
      • Principal Investigator: Lutz Müller, PD Dr.
      • Sub-Investigator: Thomas Weber, Dr.
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Not yet recruiting
      • University Hospital of Schleswig-Holstein (Campus Kiel)
      • Contact: Natalie Schub, Dr.
      • Principal Investigator: Natalie Schub, Dr.
      • Sub-Investigator: Lars Fransecky, Dr.
  • Thüringen
    • Jena, Thüringen, Germany, 07743
      • Recruiting
      • University Hospital Jena
      • Contact: Inken Hilgendorf, PD Dr.
      • Principal Investigator: Inken Hilgendorf, PD Dr.
      • Sub-Investigator: Wibke Göpel, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 < 50% and/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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (allo SCT); Allogeneic stem cell transplantation	Drug: Allogeneic Stem Cells; Allogeneic Stem Cell Transplantation
Active Comparator: 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) Alternatively, autologous stem cell transplantation may also be performed, if sufficient stem cells are still cryopreserved.	Drug: carfilzomib/lenalidomide/dexamethasone (KRD); triple regimen for first relapse should be applied according to latest Summary of Product Characteristics (SmPC) version; Drug: elotuzumab/lenalidomide/dexamethasone (ERD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: daratumumab/bortezomib/dexamethasone (DVD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: daratumumab/lenalidomide/dexamethasone (DRD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: ixazomib/lenalidomide/dexamethasone (IRD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: pomalidomide/bortezomib/dexamethasone (PVD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: carfilzomib/daratumumab/dexamethasone (KDD); triple regimen for first relapse should be applied according to latest SmPC version; Drug: Autologous Stem Cells; Autologous Stem Cell Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 5 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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.	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.	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.	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.	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.	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.	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	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	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.	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.	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.	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.	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.	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.	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.	from randomization to 5 years after randomization, an average of 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	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	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	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.	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.	at day 30 after after randomization

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Gemeinsamer Bundesausschuss (G-BA); Staburo GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Anticipated): March 1, 2028
• Study Completion (Anticipated): March 1, 2033

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: allogeneic stem cell transplantation; salvage therapy; first relapse/progression after first-line therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Pomalidomide; Lenalidomide; Daratumumab; Ixazomib; Bortezomib; Antibodies, Monoclonal; Elotuzumab
• Other Study ID Numbers: AlloRelapseMMStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No