Hodgkin's Disease, Multiple Myeloma, Non-Hodgkin-Lymphoma
Conditions
Brief summary
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
Interventions
DRUGCyclophosphamide
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation
Sponsors
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning * Written informed consent * No uncontrolled infections
Exclusion criteria
* Severe organ dysfunction defined as: * Cardiac left ventricular ejection fraction (LVEF) of less than 35% * diffusing lung capacity (DLCO) of less than 40% * total lung capacity (TLC) of less than 40% * forced expiratory volume (FEV1) of less than 40% * total bilirubin \>3mg/dl * creatinine-clearance of less than 40 ml/min * pregnancy or breast feeding * participation in other experimental drug trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients not requiring additional immunosuppression | day 100 after transplant | The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| engraftment | day 100 after transplant | absolute neutrophil count of \> 0.5 x 10e9/l on 3 consecutive days |
| chimerism | day 100 after transplant | Percentage of donor cells in leukocytes from peripheral blood or bone marrow |
| relapse incidence | day 100 after transplant | cumulative incidence of relapse until day 100 |
| Overall Survival | day 100 after transplant | — |
| non-relapse mortality | day 100 after transplant | cumulative incidence of death from any cause without prior relapse or progression of malignant disease |
| immune reconstitution | day 100 after transplant | relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood |
| acute GvHD | day 100 after transplant | cumulative incidence of acute GvHD |
Countries
Germany
Outcome results
None listed