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Natural Killer cell alloreactive bone marrow transplantation for Multiple Myeloma

Natural Killer cell alloreactive bone marrow transplantation for Multiple Myeloma - Haplo-identical bone marrow transplantation in multiple myeloma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41842
Enrollment
24
Registered
2015-03-03
Start date
2016-04-08
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmaceldyscrasia

Interventions

Donor KIR-ligand mismatched haploidentical bone marow transplantation.

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with MM

Exclusion criteria

Exclusion criteria: - Active uncontrolled infections - Patients that are known to be HIV positive. - Patients with Donor specific HLA-antibodies - 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

Design outcomes

Primary

MeasureTime frame
Progression free survival 18 weeks after transplantation.

Secondary

MeasureTime frame
1. Response rate 2. Incidence of graft failure, engraftment and time to neutrophil and platelet recovery 3. Incidence and Severity of Acute and Chronic GVHD 4. Non-Relapse Mortality 5. Evaluation of infections after haploBMT and T cell reconstitution 6. NK cell repertoire reconstitution and maturation rates including alloreactivity 7. NK cell repertoire in the Bone Marrow before and after (6 weeks) transplantation 8. Cost calculation 9. Quality of Life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)