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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON-associated MM and haplo


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

Phase II, multicenter, study to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients.


Status

open


Members

Maastricht University Medical center (MUMC), Maastricht
Investigators: Prof. G.M.J. Bos, Dr. C.H.M.J. Van Elssen
Vrije Universiteit medisch centrum (VUmc), Amsterdam
Investigator: Dr. E. Meijer
Utrecht Medisch Centrum (UMC), Utrecht
Investigator: Dr. R. Raymakers
Radboud Medisch Centrum (RaboudMC), Nijmegen
Investigator Dr. M. Schaap
Erasmus Medisch Centrum (ErasmusMC), Rotterdam
Investigator: Dr. A.E.C. Broers
Leids Universitair Centrum (LUMC), Leiden
Investigator: Dr. P. von dem Borne
Universitair Menisch Centrum Groningen (UMCG), Groningen
Investigator: Dr. M.R. de Groot



Type of study

Prospective Phase II study


Target number of patients

24


Study objectives

Primary objective
The aim 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.

Secondary objectives
Response rate (analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation).
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (analysed in the first month after transplantation).
Incidence and severity of Acute and Chronic GVHD (analyzed during follow-up of 1,5 years).
Non-Relapse Mortality after 1,5 years.
Evaluation of infections after haploBMT and T cell reconstitution (T cell reconstitution is analyzed at 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplantation).
NK cell repertoire reconstitution and maturation rates including alloreactivity (analyzed at 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplantation).
NK cell repertoire in the Bone Marrow before and after transplantation (analyzed 6 weeks post-transplantation).
Cost calculation (analyzed after 1,5 years)
Quality of Life (analyzed after 6 months and 1,5 years).


2. Patient eligibility criteria



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:
- 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 indentical 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.


3. Registration (& randomization) of patients



Registration

For clinical questions and registration of patients please contact Prof. G.M.J. Bos gerard.bos@mumc.nl or Dr. C.H.M.J. Van Elssen janine.van.elssen@mumc.nl.


4. Participating parties



Principal investigator

Principal investigators
Prof. G.M.J. Bos (gerard.bos@mumc.nl)
Dr. E. Meijer (el.meijer@vumc.nl)
Study coordinator
Dr. C.H.M.J. Van Elssen (janine.van.elssen@mumc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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