Clinical trial · Interventional
Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma
Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma
NCT02519114CI-TRIAL-00025917unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor Bone Marrow stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bone MarrowTransplantation
- description
- KIR-mismatched haploidentical bone marrow transplantation
- interventionNames
- Procedure: Donor Bone Marrow stem cell transplantation
Primary outcomes (1)
- measure
- Progression free survival (scale)
- timeFrame
- 1 year
Secondary outcomes (9)
- measure
- Response rate (scale)
- timeFrame
- analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation
- measure
- Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDVan 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. PMID 33112968