A PHASE II STUDY TO INVESTIGATE THE EFFICACY OF CYCLOPHOSPHAMIDE AS SOLE GRAFT-VERSUS-HOST-PROPHYLAXIS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION (OCTET-CY) - OCTET-CY

• Conditions: Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkins disease having undergone allogeneic stem cell transplantation; MedDRA version: 12.1Level: LLTClassification code 10028566Term: Myeloma; MedDRA version: 12.1Level: LLTClassification code 10020206Term: Hodgkin's disease; MedDRA version: 12.1Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphoma

• Registration Number: EUCTR2010-022058-18-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-03
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Primary end point:<br>•Number of patients not requiring any additional immunosuppressive treatment until day 100 after allogeneic transplantation;Secondary Objective: Secondary end point:<br>•Cumulative incidence and severity of acute GvHD<br>•Cumulative incidence of relapse<br>•Non-relapse-mortality at day +28 and +100<br>•Overall survival at day +100<br>•Haematopoietic reconstitution<br>•Donor chimerism<br>•Immune reconstitution<br>;Primary end point(s): •Number of patients not requiring any additional immunosuppressive treatment until day 100 after allogeneic transplantation