Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkins disease having undergone allogeneic stem cell transplantation MedDRA version: 12.1 Level: LLT Classification code 10028566 Term: Myeloma MedDRA version: 12.1 Level: LLT Classification code 10020206 Term: Hodgkin's disease MedDRA version: 12.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma
Conditions
Interventions
Trade Name: ENDOXAN 1g
Product Name: Cyclophosphamide
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CYCLOPHOSPHAMIDE
Concentration unit: g gram(s)
Concentration type: equa
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Patients with multiple myeloma, Non-Hodgkin’s lymphoma or Hodgkin’s disease after allogeneic stem cell transplantation with reduced intensity conditioning • Transplantation of stem cells from one of the following donors: -HLA-identical sibling donor (SIB) -HLA-matched unrelated donor (MUD) -HLA-mismatched related donor (mMRD) or unrelated donor (mMUD), if not mismatched in more than one single HLA allele • Karnofsky-Index = 80 % • No uncontrolled infections Age at least 18 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Known intolerance to cyclophosphamide • Presence of hemorrhagic cystitis or urinary tract obstruction • Presence of uncontrolled infections • Failure to use highly-effective contraceptive methods for men and women when sexually active • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator • Persons held in an institution by legal or official order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. Primary end point: • Number of patients not requiring any additional immunosuppressive treatment until day 100 after allogeneic transplantation;Secondary Objective: Secondary end point: • Cumulative incidence and severity of acute GvHD • Cumulative incidence of relapse • Non-relapse-mortality at day +28 and +100 • Overall survival at day +100 • Haematopoietic reconstitution • Donor chimerism • Immune reconstitution ;Primary end point(s): • Number of patients not requiring any additional immunosuppressive treatment until day 100 after allogeneic transplantation | — |
Countries
Germany
Outcome results
None listed