Multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: human allogeneic hematopoietic stem cells (allo-HSC) from peripheral blood stem cell (PBSC) collections
Product Name: human allogeneic hematopoietic stem cells from peripheral blood stem c
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for study inclusion must meet criteria 1-6 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) 1. Relapsed/progressed after autologous SCT (single or tandem) First line therapy comprises induction therapy followed by single or tandem autologous transplantation and maintenance therapy 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 434 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if any one of criteria 1-4 are met at registration and if criterion 5 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present clinical study aims to demonstrate the superiority of allogeneic stem (alloSCT) cell transplantation 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.;Secondary Objective: To show an improvement of progression free survival and relapse free survival after alloSCT cell transplantation compared to conventional therapy. In addition, quality of life, toxicities, recurrence rates, non-relapse mortality (NRM), remission rates including minimal residual disease (MRD) between the two arms are compared. Acute and chronic GvHD after alloSCT are evaluated. ;Primary end point(s): Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization);Timepoint(s) of evaluation of this end point: 5 years after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1, 3 and 5 years after randomization;Secondary end point(s): Secondary Endpoints: Event-free survival at 1, 3 and 5 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 1, 3 and 5 years after randomization). Event defined as: • Progression (according to IMWG criteria) or • Relapse (according to IMWG criteria) or • Engraftment Failure (defined as no neutrophil count > 0.5 x 109/L on day 28 after SCT)) or • Death of any cause Change from baseline in total EORTC score at 1, 3 and 5 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 1,3 and 5 years after randomization) Time-to first remission (partial or complete) after randomization (Patient observed from randomization until database lock for final analysis and rate of occurrence of first remission calculated as “1-Kaplan-Meier estimate” at 2 years after randomization reported) Non-relapse mortality (NRM) at 1, 3, and 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 1, 3 and 5 years after randomization reported) Cumulative incidence of Acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al. [34]) at 1, 3 and 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 1, 3 and 5 years after randomization reported) Cumulative incidence of Chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [35]) at 1, 3 and 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 1, 3 and 5 years after randomization reporte | — |
Countries
Germany
Contacts
Public ContactNicolaus Kroeger
University Medical Center Hamburg-Eppendorf
Outcome results
None listed