Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

NCT ID: NCT02519114

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-06-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bone MarrowTransplantation

KIR-mismatched haploidentical bone marrow transplantation

Group Type: EXPERIMENTAL

Donor Bone Marrow stem cell transplantation

Intervention Type: PROCEDURE

KIR-mismatched haploidentical Bone Marrow stem cell transplantation

Interventions

Donor Bone Marrow stem cell transplantation

KIR-mismatched haploidentical Bone Marrow stem cell transplantation

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gerard Bos

Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Geesing

Role: STUDY_DIRECTOR

Maastricht Medical University

Locations

Maastricht university Medical center

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Janine Elssen van, MD PhD

Role: CONTACT

janine.van.elssen@mumc.nl

31 43 3877026

Gerard MJ Bos, MD PhD

Role: CONTACT

gerard.bos@mumc.nl

31 43 3877026

Facility Contacts

Janine Van Elssen, MD, PhD

Role: primary

janine.van.elssen@mumc.nl

Gerard Bos, MD, PhD

Role: backup

gerard.bos@mumc.nl

References

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.

Reference Type: DERIVED

PMID: 33112968 (View on PubMed)

Other Identifiers

NL49476.000

Identifier Type: -

Identifier Source: org_study_id