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

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Patients with MM <66 years.
•- Poor prognosis MM patients, permissive for KIR-ligand mismatch and with a KIR-ligand mismatched haploidentical donor. Poor prognosis is based on:
•o Patients with early disease recurrence (within 12 months after first ASCT) or
•o Patients after a minimum of three lines of chemotherapy (including high dose therapy followed by ASCT rescue therapy) or
•o Poor risk based on the cytogenetic profile.
•- Written informed consent
•- If there is no HLA identical related or 10/10 matched unrelated donor
•- Permissive for KIR-ligand mismatch
•- At least partial response after reinduction therapy
•- Measurable disease

•- 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 < 30 ml/min after rehydration)
•- History of active malignancy during the past 5 years with the exception of basal cell 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).
•- Pregnant female patient. During the study pregnancy must be prevented by the use of contraceptives.

发起方

Medisch Universitair Ziekenhuis Maastricht