Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma. A phase II study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002557-38-DE

Enrollment

Registered

2017-10-09

Start date

2018-02-13

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000054086

Interventions

Trade Name: Cyclophosphamid Trockensubstanz Pharmaceutical Form: Powder for dispersion for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation - Patients age: 18 - 65 years at time of inclusion (female and male) -Performance status ECOG =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Multiple Myeloma newly diagnosed patients without detection of deletion 17p or translocation 4;14 -Severe active infection or other uncontrolled severe condition-ing -Severe renal, hepatic, pulmonary or cardiac disease, such as: • Total bilirubin, SGPT or SGOT > 3 times upper the normal level • Left ventricular ejection fraction 65 years. - Uncontrolled invasive fungal infection at time of screening (baseline) - Serious psychiatric or psychological disorders - Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of the study is chronic GvHD and progression-free survival at 2 years after transplantation.;Secondary Objective: - to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related or unrelated donor,and cyclophosphamide as post-transplant GvHD prophylaxis - to determine toxicity and safety of cyclophosphamide as GvHD prophylaxis;Primary end point(s): Chronic GvHD and progression-free survival at 2 years after allogeneic SCT;Timepoint(s) of evaluation of this end point: 2 years after allogeneic SCT	—

Measure

Time frame

Main Objective: The primary endpoint of the study is chronic GvHD and progression-free survival at 2 years after transplantation.;Secondary Objective: - to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related or unrelated donor,and cyclophosphamide as post-transplant GvHD prophylaxis - to determine toxicity and safety of cyclophosphamide as GvHD prophylaxis;Primary end point(s): Chronic GvHD and progression-free survival at 2 years after allogeneic SCT;Timepoint(s) of evaluation of this end point: 2 years after allogeneic SCT

—

Secondary

Measure	Time frame
Secondary end point(s): 1. NRM at 2 years after allogeneic SCT 2. Incidence of acute GvHD on Day +100 after allogeneic SCT 3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT 4. Toxicity according to NCI 5. Complete remission rate (including sCR and MRD negativity) 6. Overall and progression-free survival at 2 years;Timepoint(s) of evaluation of this end point: 1. NRM at 2 years after allogeneic SCT 2. Incidence of acute GvHD on Day +100 after allogeneic SCT 3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT 4. Toxicity according to NCI 5. Complete remission rate (including sCR and MRD negativity) 6. Overall and progression-free survival at 2 years	—

Measure

Time frame

Secondary end point(s): 1. NRM at 2 years after allogeneic SCT 2. Incidence of acute GvHD on Day +100 after allogeneic SCT 3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT 4. Toxicity according to NCI 5. Complete remission rate (including sCR and MRD negativity) 6. Overall and progression-free survival at 2 years;Timepoint(s) of evaluation of this end point: 1. NRM at 2 years after allogeneic SCT 2. Incidence of acute GvHD on Day +100 after allogeneic SCT 3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT 4. Toxicity according to NCI 5. Complete remission rate (including sCR and MRD negativity) 6. Overall and progression-free survival at 2 years

—

Countries

Germany

Contacts

Public ContactStudy Coordinator

Department of Stem Cell Transplantation University Medical Center Hamburg-Eppendorf

nkroeger@uke.de0049407410-54851

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026