NCT02519114

Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma

Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Donor Bone Marrow stem cell transplantation	KIR-mismatched haploidentical Bone Marrow stem cell transplantation

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-08-10
• Last updated: 2017-02-10

Locations

1 site across 1 country: Netherlands