Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma

NCT ID: NCT03700450

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2022-12-01

Brief Summary

The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.

Detailed Description

The present study is a multicenter, prospective Phase II-study 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 with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.

In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclophosphamid post Tranplant

Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide

Interventions

Cyclophosphamide

Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide

Intervention Type: DRUG

Other Intervention Names

Endoxan

Eligibility Criteria

Inclusion Criteria

1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation

2. Patients age: 18 - 65 years at time of inclusion (female and male)

3. Performance status ECOG < 2

4. Availability of haploidentical, matched or mismatched related or unrelated donor

5. Patients understand and voluntarily sign an informed consent

6. The study population includes female of childbearing potential (FOCP). FOCP have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization).

7. Men who are sexually active with FOCP must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. Contraception should be continued until 6 months after end of study.

Exclusion Criteria

1. Severe active infection or other uncontrolled severe conditioning

2. Severe renal, hepatic, pulmonary or cardiac disease, such as:

• Total bilirubin, SGPT or SGOT > 3 times upper the normal level
• Left ventricular ejection fraction < 30 %
• Creatinine clearance < 30 ml/min
• DLCO < 35 % and/or receiving supplementary continuous oxygen

3. Positive serology for HIV

4. Pregnant or lactating women (positive serum pregnancy test)

5. Women of child-bearing potential with unclear contraception

6. Age < 18 and > 65 years.

7. Uncontrolled invasive fungal infection at time of screening (baseline)

8. Serious psychiatric or psychological disorders

9. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esteve Pharmaceuticals GmbH

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaus Kröger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Countries

Germany

Other Identifiers

Allo-MM-PostCy-Study

Identifier Type: -

Identifier Source: org_study_id