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Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Donor Bone Marrow stem cell transplantation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring M Myeloma, KIR ligand mismatch, Haploidentical

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with MM <60 years.

  • Poor prognosis MM patients, permissive for KIR-ligand mismatch and with a KIR-ligand mismatched haploidentical donor. Poor prognosis is based on:

    • Patients with early disease recurrence (within 12 months after first ASCT) or
    • Patients after a minimum of three lines of chemotherapy (including high dose therapy followed by ASCT rescue therapy) or
    • Poor risk based on the cytogenetic profile.
  • Written informed consent
  • No HLA identical related or 10/10 matched unrelated donor
  • Permissive for KIR-ligand mismatch
  • Responsive after reinduction therapy
  • Measurable disease

Exclusion Criteria:

  • - Patients with an full matched (10/10) donor, who will enroll in the HOVON 96 study
  • Active uncontrolled infections
  • Uncontrolled CNS involvement by the malignant disease
  • Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
  • Severe pulmonary dysfunction (CTCAE grade III-IV)
  • Severe neurological or psychiatric disease
  • Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal)
  • Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration)
  • History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
  • Any psychological, familial, lingual, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Breast-feeding female patients.
  • Concurrent severe and/or uncontrolled medical condition (DM, hypertension, cancer).

Sites / Locations

  • Maastricht university Medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone MarrowTransplantation

Arm Description

KIR-mismatched haploidentical bone marrow transplantation

Outcomes

Primary Outcome Measures

Progression free survival (scale)

Secondary Outcome Measures

Response rate (scale)
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Incidence and Severity of Acute and Chronic GVHD (scale)
Non-Relapse Mortality (number)
Evaluation of infections after haploBMT and T cell reconstitution (scale)
NK cell repertoire reconstitution and maturation rates including alloreactivity (facs)
NK cell repertoire in the Bone Marrow before and after transplantation (facs)
Cost calculation (euro)
Quality of Life (questionnaire)

Full Information

First Posted
May 28, 2015
Last Updated
February 9, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02519114
Brief Title
Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma
Official Title
Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients.
Detailed Description
The goal of this study is to evaluate the effectiveness of a new treatment modality, the KIR-ligand mismatched haploidentical stem cell transplantation (haploBMT), for poor risk multiple myeloma (MM) patients. MM is a malignancy of plasma cells that usually resides in the bone marrow. Despite new treatment modalities that have been introduced in the last years, MM is still an incurable disease for most patients and median survival for the younger patients (<65) is about 5 years. MM can be treated by several disease modifiers - classical chemotherapy, high dose chemotherapy and autologous stem cell transplantation (ASCT), immunomodulators like thalidomide and lenalidomide, and drugs like bortezomib that interact with relevant intracellular pathways of malignant plasma cells. Though these treatment modalities have improved overall survival and quality of life, patients are not cured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
M Myeloma, KIR ligand mismatch, Haploidentical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone MarrowTransplantation
Arm Type
Experimental
Arm Description
KIR-mismatched haploidentical bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
Donor Bone Marrow stem cell transplantation
Intervention Description
KIR-mismatched haploidentical Bone Marrow stem cell transplantation
Primary Outcome Measure Information:
Title
Progression free survival (scale)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response rate (scale)
Time Frame
analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation
Title
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Time Frame
30 days after transplantation
Title
Incidence and Severity of Acute and Chronic GVHD (scale)
Time Frame
analyzed during follow-up of 1,5 years
Title
Non-Relapse Mortality (number)
Time Frame
1.5 years
Title
Evaluation of infections after haploBMT and T cell reconstitution (scale)
Time Frame
1 year after transplantation
Title
NK cell repertoire reconstitution and maturation rates including alloreactivity (facs)
Time Frame
1 year after transplantation
Title
NK cell repertoire in the Bone Marrow before and after transplantation (facs)
Time Frame
6 weeks after transplantation
Title
Cost calculation (euro)
Time Frame
1.5 years
Title
Quality of Life (questionnaire)
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with MM <60 years. Poor prognosis MM patients, permissive for KIR-ligand mismatch and with a KIR-ligand mismatched haploidentical donor. Poor prognosis is based on: Patients with early disease recurrence (within 12 months after first ASCT) or Patients after a minimum of three lines of chemotherapy (including high dose therapy followed by ASCT rescue therapy) or Poor risk based on the cytogenetic profile. Written informed consent No HLA identical related or 10/10 matched unrelated donor Permissive for KIR-ligand mismatch Responsive after reinduction therapy Measurable disease Exclusion Criteria: - Patients with an full matched (10/10) donor, who will enroll in the HOVON 96 study Active uncontrolled infections Uncontrolled CNS involvement by the malignant disease Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease) Severe pulmonary dysfunction (CTCAE grade III-IV) Severe neurological or psychiatric disease Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal) Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration) History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma Any psychological, familial, lingual, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule Breast-feeding female patients. Concurrent severe and/or uncontrolled medical condition (DM, hypertension, cancer).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine Elssen van, MD PhD
Phone
31 43 3877026
Email
janine.van.elssen@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Gerard MJ Bos, MD PhD
Phone
31 43 3877026
Email
gerard.bos@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Geesing
Organizational Affiliation
Maastricht Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht university Medical center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Van Elssen, MD, PhD
Email
janine.van.elssen@mumc.nl
First Name & Middle Initial & Last Name & Degree
Gerard Bos, MD, PhD
Email
gerard.bos@mumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33112968
Citation
Van Elssen C, van Gorkom G, Voorter C, von dem Borne P, Meijer E, Wieten L, Bos G. Haploidentical transplantation in patients with multiple myeloma making use of natural killer cell alloreactive donors. Ann Hematol. 2021 Jan;100(1):181-187. doi: 10.1007/s00277-020-04303-z. Epub 2020 Oct 28.
Results Reference
derived

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Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

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