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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03700450

Collaborator

Riemser (Other), Clinical Trial Center North (CTC North GmbH & Co. KG) (Other)

Enrollment

Locations

Arm

75.5

Anticipated Duration (Months)

12.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Cyclophosphamide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All patients will receive on day 3 and 4 after allogeneic stem cell transplan-tation 50 mg/kg BW cyclophosphamideAll patients will receive on day 3 and 4 after allogeneic stem cell transplan-tation 50 mg/kg BW cyclophosphamide

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 16, 2018

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclophosphamid post Tranplant Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide	Drug: Cyclophosphamide Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide Other Names: Endoxan

Arm

Intervention/Treatment

Experimental: Cyclophosphamid post Tranplant

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

Drug: Cyclophosphamide

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

Other Names:

Endoxan

Outcome Measures

Primary Outcome Measures

Chronic GvHD [2 years]
Chronic GvHD at 2 years after allogeneic SCT
Progression-free survival [2 years]
Progression-free survival at 2 years after allogeneic SCT

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Patients age: 18 - 65 years at time of inclusion (female and male)
Performance status ECOG < 2
Availability of haploidentical, matched or mismatched relative or unrelated donor
Patients understand and voluntarily sign an informed consent
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).
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:

Severe active infection or other uncontrolled severe conditioning
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

Positive serology for HIV
Pregnant or lactating women (positive serum pregnancy test)
Women of child-bearing potential with unclear contraception
Age < 18 and > 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg	Germany	20246
2	Universitätsklinikum Heidelberg	Heidelberg	Germany	69120
3	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz	Germany	55131