Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressed patients with multiple myeloma after first-line therapy (AlloRelapseMMStudy)

Korábbi kezelés

• 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 study inclusion/enrollment

Más betegség

• Active hepatitis B or C infection or uncontrolled HIV infection
• Other, active malignant disease
• Progressive disease (PD) on salvage therapy

Laborértékek

• Non-sufficient organ function defined as:  Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥ 3 times higher than normal values  Cardiac ejection fraction ≤ 50 %  GFR < 30 ml/min  DLCO < 35 % or continuous oxygen dependency
• Positive serum pregnancy test at screening and before first treatment or breastfeeding

Egyéb

• Patients are not included in the study if any one of criteria 1-6 are met and if criterion 7 is met before randomization:

• Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
• CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study
• 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-CRAB-criteria
• Negative pregnancy test in female patients
• Maximum of 1 cycle salvage therapy prior to study inclusion/enrollment
• 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