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

Primary Purpose

Multiple Myeloma

Status

Active

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cyclophosphamide

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Without detection of deletion 17p or translocation 4;14;, Post Cyclophosphamide, GvHD Prophylaxis, Allogeneic SCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Medical Center Hamburg-Eppendorf
Universitätsklinikum Heidelberg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamid post Tranplant

Arm Description

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

Outcomes

Primary Outcome Measures

Chronic GvHD

Chronic GvHD at 2 years after allogeneic SCT

Progression-free survival

Progression-free survival at 2 years after allogeneic SCT

Secondary Outcome Measures

Non-relapsed mortality

Non-relapsed mortality at 2 years after allogeneic SCT

Acute GvHD

Incidence of acute GvHD on Day +100 after allogeneic SCT

Chronic GvHD

Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Toxicity

Toxicity scored according to NCI CTCAE, Version 4.0

Remission

Complete remission rate (including sCR and MRD negativity)

Overall Survival

Overall survival at 2 years

Progression-free Survival

Progression-free survival at 2 years

Full Information

NCT ID

NCT03700450

First Posted

August 23, 2018

Last Updated

August 20, 2021

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03700450

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 16, 2018 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Without detection of deletion 17p or translocation 4;14;, Post Cyclophosphamide, GvHD Prophylaxis, Allogeneic SCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclophosphamid post Tranplant

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Endoxan

Intervention Description

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

Primary Outcome Measure Information:

Title

Chronic GvHD

Description

Chronic GvHD at 2 years after allogeneic SCT

Time Frame

2 years

Title

Progression-free survival

Description

Progression-free survival at 2 years after allogeneic SCT

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Non-relapsed mortality

Description

Non-relapsed mortality at 2 years after allogeneic SCT

Time Frame

2 years

Title

Acute GvHD

Description

Incidence of acute GvHD on Day +100 after allogeneic SCT

Time Frame

Day +100 after allogeneic SCT

Title

Chronic GvHD

Description

Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Time Frame

1 and 2 years after allogeneic SCT

Title

Toxicity

Description

Toxicity scored according to NCI CTCAE, Version 4.0

Time Frame

till 2 years

Title

Remission

Description

Complete remission rate (including sCR and MRD negativity)

Time Frame

till 2 years

Title

Overall Survival

Description

Overall survival at 2 years

Time Frame

2 years

Title

Progression-free Survival

Description

Progression-free survival at 2 years

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolaus Kröger, Prof. Dr.

Organizational Affiliation

Universitätsklinikum Hamburg-Eppendorf

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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