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

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.

Inclusion Criteria:Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:Multiple MyelomaAge 18 - 65 yearsA signed informed consent form must be obtained before participation in the studyAge 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 11st 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 criteriaNegative pregnancy test in female patientsMaximum of 1 cycle salvage therapy prior to study inclusionAvailability 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 therapyCR/PR or SD according to IMWG-criteria after 3 cycles salvage therapy within the studyExclusion 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 dependencyActive hepatitis B or C infection or uncontrolled HIV infectionOther, active malignant diseasePrior treatment with allogeneic stem cellsParticipation 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 registrationPositive serum pregnancy test at screening and before first treatment or breastfeedingPD under salvage therapy