atural Killer cell alloreactive bone marrow transplantation for Multiple Myeloma

Phase 2

Completed

• Conditions: Plasmaceldyscrasia; Multiple Myeloma; 10035227

• Registration Number: NL-OMON41842
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-23
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- 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

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 < 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival 18 weeks after transplantation. </p><br>

Secondary Outcome Measures

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