Corona Virus

 

 

COVID-19

 

Wat betreft HOVON:

Het HOVON Data Center (HDC) en dus ook de HOVON Safety desk blijft onveranderd operationeel om de veiligheid van de patiënten in een HOVON studie te waarborgen.

De levering van studiemedicatie wordt nauwlettend opgevolgd en indien nodig zal tijdig hierover bericht worden.

Centrale lab faciliteiten zijn onveranderd operationeel. Vooralsnog is het mogelijk om patiënten in de HOVON studies te includeren.

 

Wat betreft deelnemende site:

Indien jullie nav COVID-19 situatie de inclusie voor een studie tijdelijk stopzetten graag het HDC per email hierover informeren (mail naar hdc@erasmusmc.nl).

Verder, indien er per protocol bepaalde studie visites/handelingen niet (kunnen) plaatsvinden nav COVID-19 situatie graag documenteren in de patiënten file.

 

Contact: 

Gegeven de situatie rondom Corona virus zijn het HOVON Centraal Bureau (HCB) en het HOVON Data Center (HDC) tijdelijk telefonisch niet bereikbaar.

Graag alle (urgente) vragen via email, deze zullen zsm door het team opgepakt en verwerkt worden. Wij hopen op jullie begrip voor deze situatie.

Voor studie specifieke vragen kun je contact opnemen met de trial manager van de studie of via het algemene HDC email adres (hdc@erasmucmc.nl – voeg HOVON studie nr toe).

 

 

Met vriendelijke groet, Marleen Breems (HOVON General Director) en Bianca Backx (manager HDC)


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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON-associated MM and haplo


News
1. Overview
Study details
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

closed


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



Study details



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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