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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Cyclophosphamide

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic GvHD	Chronic GvHD at 2 years after allogeneic SCT	2 years
Progression-free survival	Progression-free survival at 2 years after allogeneic SCT	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Esteve Pharmaceuticals GmbH
• Investigators: Principal Investigator: Nicolaus Kröger, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Without detection of deletion 17p or translocation 4;14;; Post Cyclophosphamide; GvHD Prophylaxis; Allogeneic SCT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide
• Other Study ID Numbers: Allo-MM-PostCy-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No