Trial Title:
Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy
NCT ID:
NCT05675319
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Dexamethasone
Dexamethasone acetate
Lenalidomide
Bortezomib
Daratumumab
Pomalidomide
Ixazomib
Elotuzumab
BB 1101
Antibodies, Monoclonal
Conditions: Keywords:
first relapse/progression after first-line therapy
allogeneic stem cell transplantation
salvage therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Allogeneic Stem Cells
Description:
Allogeneic Stem Cell Transplantation
Arm group label:
Arm A (allo SCT)
Intervention type:
Drug
Intervention name:
carfilzomib/lenalidomide/dexamethasone (KRD)
Description:
triple regimen for first relapse should be applied according to latest Summary of Product
Characteristics (SmPC) version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
elotuzumab/lenalidomide/dexamethasone (ERD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
daratumumab/bortezomib/dexamethasone (DVD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
daratumumab/lenalidomide/dexamethasone (DRD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
ixazomib/lenalidomide/dexamethasone (IRD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
pomalidomide/bortezomib/dexamethasone (PVD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
carfilzomib/daratumumab/dexamethasone (KDD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
Autologous Stem Cells
Description:
Autologous Stem Cell Transplantation
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
daratumumab/pomalidomide/dexamethasone (DPD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
isatuximab/carfilzomib/dexamethasone (Isa-KD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Intervention type:
Drug
Intervention name:
selinexor/bortezomib/dexamethasone (SVD)
Description:
triple regimen for first relapse should be applied according to latest SmPC version
Arm group label:
Arm B (conventional therapy)
Summary:
Allogeneic stem cell (allo SCT) transplantation for multiple myeloma is a potential
curative treatment, but is associated with morbidity and treatment related mortality.
Approved drug combinations or another autologous stem cell transplantation (auto-SCT) can
be used for relapsed patients resulting in a median progression free survival up to 2-3
years.
In the current trial after first-line treatment relapsed or progressed myeloma patients
with an HLA compatible donor will be randomized after 3 cycles of salvage therapy to
allogeneic stem cell transplantation or to continuous conventional salvage therapy.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ralph Wäsch, Prof. Dr.
Investigator:
Last name:
Ralph Wäsch, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Monika Engelhardt, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stefan Schönland, Prof. Dr.
Investigator:
Last name:
Stefan Schönland, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Ute Hegenbart, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
Robert-Bosch Hospital Stuttgart
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Kaufmann, Dr.
Investigator:
Last name:
Martin Kaufmann, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Sonja Martin, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wolfgang Bethge, Prof. Dr.
Investigator:
Last name:
Wolfgang Bethge, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Britta Besemer, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Christoph Faul, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital of Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Elisa Sala, Dr.
Investigator:
Last name:
Elisa Sala, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Miriam Knull, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Augsburg
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christoph Schmid, Pof. Dr.
Investigator:
Last name:
Christoph Schmid, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Tim Pfeiffer, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Munich ( LMU)
Address:
City:
München
Zip:
80336
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Johanna Tischer, PD Dr.
Investigator:
Last name:
Johanna Tischer, PD Dr.
Email:
Principal Investigator
Investigator:
Last name:
Sebastian Theurich, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
Munich Hospital Schwabing
Address:
City:
München
Zip:
80804
Country:
Germany
Status:
Withdrawn
Facility:
Name:
University Hospital of the Technical University Munich rechts der Isar
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mareike Verbeek, Dr.
Investigator:
Last name:
Mareike Verbeek, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Peter Herhaus, Dr.
Email:
Sub-Investigator
Facility:
Name:
Hospital North Nürnberg
Address:
City:
Nürnberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Kerstin Schäfer-Eckart, Dr.
Investigator:
Last name:
Kerstin Schäfer-Eckart, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Knut Wendelin, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Matthias Edinger, Prof. Dr.
Investigator:
Last name:
Matthias Edinger, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Daniel Wolff, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital of Würzburg
Address:
City:
Würzburg
Zip:
97070
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sabrina Kraus, Dr.
Investigator:
Last name:
Sabrina Kraus, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Jochen Frietsch, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Frankfurt/ Main
Address:
City:
Frankfurt am Main
Zip:
60590
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ivana von Metzler, Dr.
Investigator:
Last name:
Ivana von Metzler, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Fabian Lang, Dr.
Email:
Sub-Investigator
Facility:
Name:
Philipps University Marburg
Address:
City:
Marburg
Zip:
35037
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Andreas Burchert, Prof. Dr.
Investigator:
Last name:
Andreas Burchert, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Kristina Sohlbach, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Medical Center Göttingen
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wolfram Jung, Dr.
Investigator:
Last name:
Wolfram Jung, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Justin Hasenkamp, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital RWTH Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Edgar Jost, Prof. Dr.
Investigator:
Last name:
Edgar Jost, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Deniz Gezer, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Bonn
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tobias Holderried, Dr.
Investigator:
Last name:
Tobias Holderried, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Martin Schumacher, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Düsseldorf
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Guido Kobbe, Prof. Dr.
Investigator:
Last name:
Guido Kobbe, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Roland Fenk, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Schroeder, PD Dr.
Investigator:
Last name:
Thomas Schroeder, PD Dr.
Email:
Principal Investigator
Investigator:
Last name:
Christina Rautenberg, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Münster
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Matthias Stelljes, Prof. Dr.
Investigator:
Last name:
Matthias Stelljes, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Evgenii Shumilov, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Medical Center Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Eva Maria Wagner-Drouet, Dr.
Investigator:
Last name:
Eva Maria Wagner-Douret, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Beate Hauptrock, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Halle (Saale)
Address:
City:
Halle (Saale)
Zip:
06120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Lutz Müller, apl. Prof. Dr.
Investigator:
Last name:
Lutz Müller, apl. Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Thomas Weber, PD Dr.
Email:
Sub-Investigator
Facility:
Name:
Hospital of Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mathias Hänel, PD Dr.
Investigator:
Last name:
Mathias Hänel, PD Dr.
Email:
Principal Investigator
Investigator:
Last name:
Anke Morgner, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Carl Gustav Carus
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Raphael Teipel, Dr.
Investigator:
Last name:
Raphael Teipel, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Karolin Trautmann-Grill, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital of Schleswig-Holstein (Campus Kiel)
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Natalie Schub, Dr.
Investigator:
Last name:
Natalie Schub, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Lars Fransecky, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Hospital Jena
Address:
City:
Jena
Zip:
07743
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Inken Hilgendorf, apl. Prof. Dr.
Investigator:
Last name:
Inken Hilgendorf, apl. Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Wibke Göpel, Dr.
Email:
Sub-Investigator
Facility:
Name:
Charité - University of Medicine Berlin
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Igor-Wolfgang Blau, Prof. Dr.
Investigator:
Last name:
Igor-Wolfgang Blau, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Giang Lam Vuong, Dr.
Email:
Sub-Investigator
Facility:
Name:
Helios Hospital Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Judith Niederland, Dr.
Investigator:
Last name:
Judith Niederland, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Julia Pross, Dr.
Email:
Sub-Investigator
Facility:
Name:
Asklepios Hospital Hamburg St. Georg
Address:
City:
Hamburg
Zip:
20099
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ahmet Elmaagacli, Prof. Dr.
Investigator:
Last name:
Ahmet Elmaagacli, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Hans Salwender, Dr.
Email:
Sub-Investigator
Facility:
Name:
University Medical Center Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Nicolaus Kröger, Prof. Dr.
Investigator:
Last name:
Nicolaus Kröger, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Christine Wolschke, Dr.
Email:
Sub-Investigator
Facility:
Name:
Hospital Oldenburg (AöR)
Address:
City:
Oldenburg
Zip:
26133
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christoph Kimmich, Dr.
Investigator:
Last name:
Christoph Kimmich, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Jochen Casper, Prof. Dr.
Email:
Sub-Investigator
Start date:
March 3, 2023
Completion date:
March 2033
Lead sponsor:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Collaborator:
Agency:
Gemeinsamer Bundesausschuss (G-BA)
Agency class:
Other
Collaborator:
Agency:
Staburo GmbH
Agency class:
Other
Source:
Universitätsklinikum Hamburg-Eppendorf
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675319
