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

NCT03700450 | Completed Phase 2 DMC

• 1 other identifier: Allo-MM-PostCy-Study
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Non-relapsed mortality

  2 years

• Acute GvHD

  Day +100 after allogeneic SCT

• Chronic GvHD

  1 and 2 years after allogeneic SCT

• Toxicity of cyclophosphamide

  till 2 years

• Remission rate

  till 2 years

Study Arms (1)

Cyclophosphamid post Tranplant

EXPERIMENTAL

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

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

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

Also known as: Endoxan

Cyclophosphamid post Tranplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation
• Performance status ECOG \< 2
• Availability of haploidentical, matched or mismatched related 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Esteve Pharmaceuticals GmbH: collaborator

Study Sites (3)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Nicolaus Kröger, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: October 9, 2018
• Study Start: March 16, 2018
• Primary Completion: November 22, 2022
• Study Completion: December 1, 2022
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)