NCT02519114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 28, 2015

Last Update Submit

February 9, 2017

Conditions

Multiple Myeloma

Keywords

M MyelomaKIR ligand mismatchHaploidentical

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (scale)

    1 year

Secondary Outcomes (9)

  • Response rate (scale)

    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)

    30 days after transplantation

  • Incidence and Severity of Acute and Chronic GVHD (scale)

    analyzed during follow-up of 1,5 years

  • Non-Relapse Mortality (number)

    1.5 years

  • Evaluation of infections after haploBMT and T cell reconstitution (scale)

    1 year after transplantation

  • +4 more secondary outcomes

Study Arms (1)

Bone MarrowTransplantation

EXPERIMENTAL

KIR-mismatched haploidentical bone marrow transplantation

Procedure: Donor Bone Marrow stem cell transplantation

Interventions

Donor Bone Marrow stem cell transplantationPROCEDURE

KIR-mismatched haploidentical Bone Marrow stem cell transplantation

Bone MarrowTransplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht university Medical center

Maastricht, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33112968DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Claudia Geesing

    Maastricht Medical University

    STUDY DIRECTOR

Central Study Contacts

Janine Elssen van, MD PhD

CONTACT

31 43 3877026janine.van.elssen@mumc.nl

Gerard MJ Bos, MD PhD

CONTACT

31 43 3877026gerard.bos@mumc.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

May 28, 2015

First Posted

August 10, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)