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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 143 MM


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


HO143

09-07-2018

FOR THE NETHERLANDS ONLY:

New Protocol, ICF and Pre-ICF forms available. From today these documents must be used.

HOVON143 MM ICF version  3.2  17mei2018

HOVON143 MM Pre-ICF version  2.2  17mei2018

HOVON143 protocol v4.0  17may2018

Please send in your local updated ICF and Pre-ICF versions to the HDC for approval.

Please send original signed Local Investigator signature page to the HDC.

 

See also email correspondence:

HOVON143 Protocol en ICF amendement activatie in NEDERLAND.msg

(dd 09jul2018)

 

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13-03-2018

The HOVON Data Center has a new postal address.

Due to this change new versions of the QoL and Assessment CRFs were made (dd 05mar2018)

 

Please use these new CRF versions to avoid lost of questionnaires.

 

New version of the "HO143 MM Instruction for IMWG Frailty Score  calculation" is also available. 

HO143 MM Instruction for IMWG Frailty Score  calculation vs 3 05mar 2018.pdf

In this new version the link to the site for Frailty score calculation is changed.

 

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04-01-2018

New ICF and Pre-ICF forms available. From today these forms must be used.

HOVON143 MM ICF version  3.1  16nov2017

 

HOVON143 MM Pre-ICF form version  2.1  16nov2017

Please send in your local updated ICF and Pre-ICF versions to the trial manager Sonia Cunha for approval.

See also email correspondence:

HOVON143 ICF amendement activatie en updated ABR form vs 9 dd 05-12-2017 n.a.v. site amendement.msg

(dd 04jan2018)

 

Updated ABR form version 9 05dec2017 available

ABR form vs 9 approved (due to site amendment)

 

HOVON143 ICF v3.1 NL_16nov2017_Final_ for sites.doc

HOVON143 pre-study ICF v2.1 16nov2017_Fnal for sites.docx

HOVON143 cumulative-VUmc METC  approvals vs 22dec2017.pdf

HOVON143 cumulative-CA  approvals vs 22dec2017.pdf

HOVON143 ABR ABR-formulier voor dossier NL59458.029 vs 8 dd 16-11-2017_tracked changes.pdf

HOVON143 ABR ABR-formulier voor dossier NL59458.029 vs 9 dd 05-12-2017signed.pdf

 

 

-----------------------------------------------------------------------------------------------------------------------------18-12-2017

New SAE form version 02 available

See also email correspondence:

HOVON143 MM new SAE form vs 02 dd 04SEP2017.msg (dd 18-dec-2017)

 

 

hovon143_sae-report-form_vs 02 04SEP2017.pdf

 

Please use this form to report new SAEs

 

 

-----------------------------------------------------------------------------------------------------------------------------03-11-2017

 

Transition to 400 mg daratumumab vials

See also email correspondence:

HOVON143 transition daratumumab from 100 mg to 400 mg vials in The Netherlands.msg (dd 03-nov-2017)

 

The new version of the 400 mg daratumumab vials (vs 2 17-08-2017) received central approval

Please use the 400 mg vials Daratumumab ressuply form for daratumumab orders.

 

HOVON143 Daratumumab 400 mg vials_144-16-342 - Resupply Drug Order Request Form_v4.pdf

HO143 MM Pharmacy info letter vs02_03nov2017.pdf

 

 

 

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26-09-2017

New version Statement of Expenses form NL vs 30-08-2017 available

 

HOVON143 Statement of Expenses form NL 30-8-2017.pdf

 

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07-09-2017

The new version of the protocol (vs 3.1 dd 17.jul.2017) received central approval

Please send in your signed local investigators protocol page.

 

New study documents that can be downloaded from the HOVON  website:

 

  • HOVON143- pro v3.1  17JUL2017 -signed.pdf
  • HOVON143- sheme of study vs 3.1,  17jul2017.pdf
  • HOVON143- Protocol summary of changes vs 1 04sep2017.pdf
  • HOVON143 cumulative-CA  approvals vs 04sep2017.pdf
  • HOVON143 cumulative-VUmc METC  approvals vs 04sep2017.pdf
  • HO143 Study drug accountability form_Daratumumab vs 2.0.pdf
  • HO143 Study drug accountability form_Ixazomib vs 2.0.pdf

>

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31-08-2017:

Study documents available: ITF labels and Drug Administration/toedienings_protocol:

  • HOVON143_ITF_Table of Contents_v1.0_24aug2017.docx;
  • HOVON143_ITF_spine label_v1.0_24aug2017.docx;
  • HOVON143_ITF_labels_v1.0_24aug2017.doc;
  • HOVON143_ITF_toelichting_lokaal_v2_28feb2017.pdf
  • HOVON143_Toedienings_Moederprotocol_ UMCA vs 3.0 30aug2017.pdf

1. Overview



Summary

Efficacy and tolerability of ixazomib, daratumumab and low dose dexamethasone (IDd) followed by ixazomib and daratumumab maintenance therapy until progression for a maximum of 2 years in unfit and frail newly diagnosed multiple myeloma patients; an open-label phase II trial


Status

open


Members

HOVON



Uitleg patienten informatie

Beste patient, hieronder vindt u een link naar de patienten informatie die beschikbaar is voor deze studie. Mochten er vragen zijn, dan kunt u deze het beste stellen aan uw behandelend arts.

 Patienten informatie


Study details



Type of study

Prospective Phase II study


Echelon level

Level D


Type of monitoring for this study

Site evaluation visits


Target number of patients

132


Date of first EC&CA submission

24-Jan-2017


Date of activation

26-Jul-2017


Approved by

EudraCT nr.:2016-002600-90
CKTO:projectnummer 10668
METC-VUMC: 2017.083
Approval date METC: 19-06-2017


2. Patient eligibility criteria



Inclusion criteria

• Previously untreated patients with a confirmed diagnosis of multiple myeloma according to IMWG criteria (see appendix A);
• Measurable disease according to the IMWG criteria (see appendix A);
(If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation)
•Patients who are either unfit or frail according to the IMWG criteria (see appendix B);
• Age 18 years or older;
• Absolute neutrophil count (ANC) ≥ 1.0 x109/l and platelet count ≥ 75x109/l , unless related to bone marrow infiltration by malignant plasma cells;
Platelet transfusions and G-CSF to help patients meet eligibility criteria are not allowed;
• Written informed consent, including consent for additional bone marrow and blood sampling and a skin biopsy (with the understanding that consent may be withdrawn by the patient at any time without consequences to future medical care);
• Patient is capable of giving informed consent;
• Negative pregnancy test at study entry (only for women of childbearing potential);
• Male patients and female patients of childbearing potential must agree to use adequate contraception from the time of signing the informed consent form through 90 days after the last dose of study drug (see section 9.4 for details).


Exclusion criteria

• Non-secretory MM;
• Plasma cell leukemia;
• Systemic Amyloid Light-chain (AL) amyloidosis;
• Central nervous system involvement;
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent;
• Neuropathy, grade 1 with pain or grade ≥ 2;
• Severe cardiac dysfunction (NYHA classification III-IV, appendix D);
• Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >470 msec;
• Chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal;
• Moderate or severe persistent asthma within the past 2 years or currently uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study);
• Significant hepatic dysfunction (total bilirubin ≥ 3 x ULN or transaminases ≥ 5 times normal level) except patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubin;
• Creatinine clearance <20 ml/min or Calculated Glomerular Filtration Rate [ml/min/1.73m2] <20;
• Patients with active, uncontrolled infections;
• Patients known to be Human Immunodeficiency Virus (HIV)-positive;
• Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing;
• Active malignancy other than MM requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity;
• Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John’s wort;
• Pre-treatment with cytostatic drug, immunomodulatory drugs (IMiDs) or proteasome inhibitors. Radiotherapy (provided the involved field is small and there are ≥ 7 days between radiotherapy and administration of ixazomib) or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed;
• Major surgery within 14 days before enrollment;
• Any serious medical or psychiatric illness, or familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial;
• Female patients who are lactating.


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
1
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Brussel-Universitair Ziekenhuis Brussel
0
BE-Bruxelles-Cliniques Universitaires St. Luc
1
BE-Haine-Saint-Paul-Hopital de Jolimont
2
BE-Ieper-Jan Yperman Ziekenhuis
1
NL-Alkmaar-MC Alkmaar
2
NL-Almere-Flevoziekenhuis
0
NL-Amersfoort-Meander MC
1
NL-Amstelveen-Ziekenhuis Amstelland
3
Show 38 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol

 Patient Information & IC form (NL)



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