Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy (AlloRelapseMM)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring first relapse/progression after first-line therapy, allogeneic stem cell transplantation, salvage therapy
Eligibility Criteria
Inclusion Criteria: 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 criteria 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 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 < 50% and/or continuous oxygen dependency Active hepatitis B or C infection or uncontrolled HIV infection Other, active malignant disease Prior treatment with allogeneic stem cells 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
Sites / Locations
- University Hospital of Freiburg
- University Hospital Heidelberg
- Robert-Bosch Hospital StuttgartRecruiting
- University Hospital Tübingen
- University Hospital of Ulm
- University Hospital AugsburgRecruiting
- University Hospital Munich ( LMU)
- Munich Hospital Schwabing
- University Hospital of the Technical University Munich rechts der Isar
- Hospital North Nürnberg
- University Hospital Regensburg
- University Hospital of WürzburgRecruiting
- University Hospital Frankfurt/ MainRecruiting
- Philipps University MarburgRecruiting
- University Medical Center Göttingen
- University Hospital RWTH Aachen
- University Hospital BonnRecruiting
- University Hospital Düsseldorf
- University Hospital Essen
- University Hospital Münster
- University Medical Center Mainz
- University Hospital Halle (Saale)
- Hospital of Chemnitz gGmbHRecruiting
- University Hospital Carl Gustav CarusRecruiting
- University Hospital of Schleswig-Holstein (Campus Kiel)
- University Hospital JenaRecruiting
- Charité - University of Medicine Berlin
- Helios Hospital Berlin-BuchRecruiting
- Asklepios Hospital Hamburg St. Georg
- University Medical Center Hamburg-EppendorfRecruiting
- Hospital Oldenburg (AöR)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (allo SCT)
Arm B (conventional therapy)
Allogeneic stem cell transplantation
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.