Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

Multiple Myeloma Clinical Trial

— OCTET-CY  

Official title:

A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283776
• Other study ID #: Uni-Koeln-1430
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2011
• Last updated: June 8, 2014
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Hodgkin-Lymphoma

Intervention

Drug:
• Cyclophosphamide
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients not requiring additional immunosuppression	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	day 100 after transplant	Yes
Secondary	Overall Survival		day 100 after transplant	Yes
Secondary	engraftment	absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days	day 100 after transplant	Yes
Secondary	chimerism	Percentage of donor cells in leukocytes from peripheral blood or bone marrow	day 100 after transplant	Yes
Secondary	relapse incidence	cumulative incidence of relapse until day 100	day 100 after transplant	No
Secondary	acute GvHD	cumulative incidence of acute GvHD	day 100 after transplant	Yes
Secondary	non-relapse mortality	cumulative incidence of death from any cause without prior relapse or progression of malignant disease	day 100 after transplant	Yes
Secondary	immune reconstitution	relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood	day 100 after transplant	No