Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

February 9, 2017 updated by: Gerard Bos, Maastricht University Medical Center

Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (scale)
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Director: Claudia Geesing, Maastricht Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49476.000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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