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

Multiple Myeloma Clinical Trial

Official title:

Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03700450
• Other study ID #: Allo-MM-PostCy-Study
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 16, 2018
• Est. completion date: July 2024

Study information

• Verified date: August 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myelo-ma 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 relative 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Clinical Trial Center North (CTC North GmbH & Co. KG), Riemser

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic GvHD	Chronic GvHD at 2 years after allogeneic SCT	2 years
Primary	Progression-free survival	Progression-free survival at 2 years after allogeneic SCT	2 years
Secondary	Non-relapsed mortality	Non-relapsed mortality at 2 years after allogeneic SCT	2 years
Secondary	Acute GvHD	Incidence of acute GvHD on Day +100 after allogeneic SCT	Day +100 after allogeneic SCT
Secondary	Chronic GvHD	Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT	1 and 2 years after allogeneic SCT
Secondary	Toxicity	Toxicity scored according to NCI CTCAE, Version 4.0	till 2 years
Secondary	Remission	Complete remission rate (including sCR and MRD negativity)	till 2 years
Secondary	Overall Survival	Overall survival at 2 years	2 years
Secondary	Progression-free Survival	Progression-free survival at 2 years	2 years