Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of the following criteria before randomization:
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 < 35 % 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
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups
Loading...
Central trial contact
Nicolaus Kröger, Prof. Dr.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal