Corona Virus





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

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



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. Indien terugbellen noodzakelijk is, graag dit aangeven in de email. 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 ( – 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 147 SMM

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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HO147 study news

Recently we sent out the approval for protocol v4.0.
There has been an unfortunate mistake, where the treatment days of Dexamethasone in Arm B (protocol page 20) have been removed. This is incorrect. Arm A and Arm B receive the same dosing of Dexamethasone on days 1, 2, 8, 9, 15, 16, 22 and 23.
The correct treatment days are shown in the treatment schedule on page 4 of the protocol.

1. Overview


Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase II Study.




HOVON, USA, Italy (EMN), Czech Republic (CMG), Norway

 Patienten informatie

Study details

Type of study

Prospective randomized Phase II study

Echelon level

Level C-HIC

Target number of patients


Date of first EC&CA submission


Approved by

central EC Erasmus MC

Study objectives

Primary objectives
To assess the progression-free survival rate of KRd versus Rd in patients with high-risk SMM 4
To assess MRD status
To assess the correlation between PFS and MRD

Secondary objectives
To determine progression-free survival-2 (PFS2)
To determine duration of response (DOR)
To determine overall survival (OS)
To assess correlation of MRD status with PFS2, DOR and OS
To evaluate toxicity of combination therapy (carfilzomib, lenalidomide, and dexamethasone).
To evaluate disease heterogeneity in relation to clinical outcomes (molecular profiling on bone marrow samples)

2. Patient eligibility criteria

Inclusion criteria

Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma based on the 2014 International Myeloma Working Group Criteria:

>> Serum M-protein ≥30 g/L, or urinary monoclonal protein >500 mg per 24 hours, and/or monoclonal bone marrow plasma cells ≥10-60 %
>>Absence of CRAB symptoms:
anemia: Hemoglobin <6.2 mmol/L (10 g/dl) or a hemoglobin value of >1.2 mmol/L (2 g/dL) below the lower limit of normal
renal failure: serum creatinine > 2.0 mg/dL or creatinine clearance < 40 ml/min
hypercalcemia: serum calcium >0·25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2·75 mmol/L (>11 mg/dL)
Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
>> Absence of myeloma defining events:
Involved/uninvolved serum free light chain ratio ≥100 with involved free light-chain concentration ≥10 mg/dl
Presence of 2 or more focal lesions by MRI (2 of which at least 5 mm)
Clonal bone marrow plasma cell percentage ≥60%

Patients must have high risk Smoldering Multiple Myeloma based on the Mayo Clinic or the PETHEMA criteria:
>> 3 factors of Mayo Clinic criteria:
Bone marrow plasma cells ≥10 %
Serum M-protein ≥ 3 g/dl
Serum free light-chain ratio <0.125 or >8
>> Or 2 factors of PETHEMA criteria:
≥95% abnormal plasma cells including decreased CD38 expression, expression of CD56, and absence of CD19 and/or CD45
Immunoparesis, a reduction (below the lower normal limit) in the levels of 1 or 2 of the uninvolved immunoglobulins (Ig)

Measurable disease defined by any one of the following:
>> Serum monoclonal protein ≥ 1.0 g/dl
>> Urine monoclonal protein >200 mg/24 hour
>> Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)

Age >18 years
WHO/ECOG performance status <2 (see Appendix C).
Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count >1.0 109 /L
Platelets ≥75 ×109 /L
Hemoglobin ≥10 g/dL (>6.2 mmol/l)
Total bilirubin <1.5 x institutional upper limit of normal
AST(SGOT)/ALT(SGPT) ≤3.0 × institutional upper limit of normal
Creatinine Clearance ≥ 50 ml/min. CrCl will be calculated by Cockcroft-Gault method. CrCl = [(140 – Age) x Mass (kg)] / [72 x Serum Creatinine (mg/dL)(x [0.85 if Female). If calculated CrCl based on Cockcroft-Gault method is <50 mL/min, patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be ≥50 ml/min.
Females of childbearing potential must have a negative serum or urine pregnancy test within 10 - 14 days prior to entry and again within 24 hours of starting lenalidomide treatment; (see 9.1.4
Patients must be willing and capable to use adequate contraception during and after the therapy (all men, all pre-menopausal women) (see 9.1.4.); Patients must be able to adhere to the requirements of the Lenalidomide Clinical Trial Pregnancy Prevention Plan;
Written informed consent
Patient is capable of giving informed consent

Exclusion criteria

Patients with symptomatic multiple myeloma (i.e. having myeloma defining events)
Amyloid Light-chain (AL) amyloidosis
Patients who are receiving any other investigational agents.
Concurrent systemic treatment or prior therapy within 4 weeks for SMM (if a patient has received any previous SMM therapy this must be discussed with the Principal Investigator before inclusion in the trial).
Treatment with corticosteroids for other indications is permitted
Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
History of allergic reactions attributed to immunomodulatory agents and proteasome inhibitors
Uncontrolled hypertension or diabetes
Pregnant or lactating females.
Significant cardiovascular disease with NYHA grade III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
Active hepatitis B or C infection
Known or suspected HIV infection
Incidence of gastrointestinal disease that would prevent absorption.
Significant neuropathy ≥Grade 3 or grade 2 with pain within 14 days of enrollment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 5 years
Major surgery within 1 month prior to enrollment
Pre-existing pulmonary, cardiac or renal impairement that prevents hydration measures as described at paragraph 9.1.4
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

3. Registration (& randomization) of patients


Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:
♦ By ALEA; select the [patient] tab and click the [ Add new patient] button. Complete all items and click the [Submit] button
♦ By faxing the completed registration/randomization CRF +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET
♦ By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00

4. Participating parties

5. Participating sites

6. Instruction videos

7. Download documentation / forms


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