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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700450
Recruitment Status : Active, not recruiting
First Posted : October 9, 2018
Last Update Posted : August 23, 2021
Sponsor:
Collaborators:
Riemser
Clinical Trial Center North (CTC North GmbH & Co. KG)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 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 : March 16, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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 Name: Endoxan


Outcome Measures
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Primary Outcome Measures :
  1. Chronic GvHD [ Time Frame: 2 years ]
    Chronic GvHD at 2 years after allogeneic SCT

  2. Progression-free survival [ Time Frame: 2 years ]
    Progression-free survival at 2 years after allogeneic SCT


Secondary Outcome Measures :
  1. Non-relapsed mortality [ Time Frame: 2 years ]
    Non-relapsed mortality at 2 years after allogeneic SCT

  2. Acute GvHD [ Time Frame: Day +100 after allogeneic SCT ]
    Incidence of acute GvHD on Day +100 after allogeneic SCT

  3. Chronic GvHD [ Time Frame: 1 and 2 years after allogeneic SCT ]
    Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

  4. Toxicity [ Time Frame: till 2 years ]
    Toxicity scored according to NCI CTCAE, Version 4.0

  5. Remission [ Time Frame: till 2 years ]
    Complete remission rate (including sCR and MRD negativity)

  6. Overall Survival [ Time Frame: 2 years ]
    Overall survival at 2 years

  7. Progression-free Survival [ Time Frame: 2 years ]
    Progression-free survival at 2 years


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700450


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Riemser
Clinical Trial Center North (CTC North GmbH & Co. KG)
Investigators
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Principal Investigator: Nicolaus Kröger, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03700450    
Other Study ID Numbers: Allo-MM-PostCy-Study
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Without detection of deletion 17p or translocation 4;14;
Post Cyclophosphamide
GvHD Prophylaxis
Allogeneic SCT
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
 Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists