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Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02519114
Recruitment Status : Recruiting
First Posted : August 10, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Gerard Bos, Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Donor Bone Marrow stem cell transplantation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma
Study Start Date : August 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Bone MarrowTransplantation
KIR-mismatched haploidentical bone marrow transplantation
Procedure: Donor Bone Marrow stem cell transplantation
KIR-mismatched haploidentical Bone Marrow stem cell transplantation




Primary Outcome Measures :
  1. Progression free survival (scale) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Response rate (scale) [ Time Frame: analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation ]
  2. Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology) [ Time Frame: 30 days after transplantation ]
  3. Incidence and Severity of Acute and Chronic GVHD (scale) [ Time Frame: analyzed during follow-up of 1,5 years ]
  4. Non-Relapse Mortality (number) [ Time Frame: 1.5 years ]
  5. Evaluation of infections after haploBMT and T cell reconstitution (scale) [ Time Frame: 1 year after transplantation ]
  6. NK cell repertoire reconstitution and maturation rates including alloreactivity (facs) [ Time Frame: 1 year after transplantation ]
  7. NK cell repertoire in the Bone Marrow before and after transplantation (facs) [ Time Frame: 6 weeks after transplantation ]
  8. Cost calculation (euro) [ Time Frame: 1.5 years ]
  9. Quality of Life (questionnaire) [ Time Frame: 1.5 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT02519114


Contacts
Contact: Janine Elssen van, MD PhD 31 43 3877026 janine.van.elssen@mumc.nl
Contact: Gerard MJ Bos, MD PhD 31 43 3877026 gerard.bos@mumc.nl

Locations
Netherlands
Maastricht university Medical center Recruiting
Maastricht, Netherlands
Contact: Janine Van Elssen, MD, PhD       janine.van.elssen@mumc.nl   
Contact: Gerard Bos, MD, PhD       gerard.bos@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Claudia Geesing Maastricht Medical University

Responsible Party: Gerard Bos, Prof Dr, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02519114     History of Changes
Other Study ID Numbers: NL49476.000
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gerard Bos, Maastricht University Medical Center:
M Myeloma
KIR ligand mismatch
Haploidentical

Additional relevant MeSH terms:
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