Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

NCT02990338 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC14335U1111-1180-62622016-003097-41
• Study Type: interventional
• Target: 307
• Locations: 24 countries
• Sites: 111

Brief Summary

Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives:

• To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
• To compare the Overall Survival (OS) between the two arms.
• To evaluate the Time To Progression (TTP) in each arm.
• To evaluate the PFS in high risk cytogenetic population in each arm.
• To evaluate the Duration of Response (DOR) in each arm.
• To evaluate the safety in both treatment arms.
• To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
• To evaluate the immunogenicity of isatuximab.
• To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

Conditions

Plasma Cell Myeloma

Keywords

Anti-CD38 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of \>=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be \>=0.5gram(g)/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24hour), appearance of new lesion(s),\>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis.

  From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)

Secondary Outcomes (23)

• Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)

  From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)

• Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee

  From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)

• Percentage of Participants With Very Good Partial Response (VGPR) or Better as Per Independent Response Committee

  From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)

• Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit as Per Independent Response Committee

  From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)

• Overall Survival (OS): Final Analysis

  From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)

Study Arms (2)

Pd (pomalidomide + dexamethasone)

ACTIVE COMPARATOR

Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants greater than or equal to (\>=) 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).

Drug: Pomalidomide; Drug: Dexamethasone

IPd (isatuximab + pomalidomide + dexamethasone)

EXPERIMENTAL

Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).

Drug: Isatuximab; Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Isatuximab DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Also known as: SAR650984, Sarclisa

IPd (isatuximab + pomalidomide + dexamethasone)

Pomalidomide DRUG

Pharmaceutical form: capsule Route of administration: oral

Also known as: POMALYST IMNOVID

IPd (isatuximab + pomalidomide + dexamethasone); Pd (pomalidomide + dexamethasone)

Dexamethasone DRUG

Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous

IPd (isatuximab + pomalidomide + dexamethasone); Pd (pomalidomide + dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age superior or equal to 18 years or country's legal age of majority if the legal age was superior to 18 years old.
• Participants had a documented diagnosis of multiple myeloma with evidence of measurable disease i.e. serum M protein superior or equal to 0.5 grams per decilitre (g/dL) measured using serum protein immunoelectrophoresis and or urine M protein superior or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis.
• Participants had received at least 2 prior lines of anti-myeloma therapy, which must include at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
• Participants had failed treatment with lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination (Intolerant, progression within 6 months after reaching Partial Response or better).
• Participants had progressed on or within 60 days after end of previous therapy before to study entry, i.e., refractory to the last line of treatment.

You may not qualify if:

• Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
• Free Light Chain measurable disease only.
• Prior therapy with pomalidomide.
• Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
• Eastern Cooperative Oncology Group performance status superior to 2.
• Platelets inferior to 75 000 cells per microliter (mcL) if inferior to 50% of bone marrow (BM) nucleated cells are plasma cells, and inferior to 30 000 cells per mcL if superior or equal to 50% of BM nucleated cells are plasma cells. Platelet transfusion was not allowed within three days before the screening visit.
• Absolute neutrophil count inferior to 1000 per mcL (1\*10\^9/L).
• Creatinine clearance inferior to 30 mL per minute (Modification of Diet in Renal Disease \[MDRD\] Formula).
• Total bilirubin superior to 2\*ULN (Upper Limit of Normal).
• Corrected serum calcium superior to 14 milligrams per deciliter (mg/dL) (superior to 3.5 millimoles per liter (mmol/L).
• Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) superior to 3\*ULN.
• Hypersensitivity to immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide) defined as any hypersensitivity reaction leading to stop IMiDs within the 2 first cycles or toxicity, which does meet intolerance definition.
• Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, or H2 blockers that would prohibit further treatment with these agents.
• Significant cardiac dysfunction; myocardial infarction within 12 months; unstable, poorly controlled angina pectoris.
• Pregnant or breastfeeding woman or female who intends to become pregnant during the participation in the study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (111)

BRCR Medical Center Inc. Site Number : 8400002

Plantation, Florida, 33324, United States

Location

Dana Farber Site Number : 8400006

Boston, Massachusetts, 02215, United States

Location

Investigational Site Number : 0360004

St Leonards, New South Wales, 2065, Australia

Location

Investigational Site Number : 0360001

Waratah, New South Wales, 2298, Australia

Location

Investigational Site Number : 0360005

Melbourne, Victoria, 3000, Australia

Location

Investigational Site Number : 0360002

Melbourne, Victoria, 3004, Australia

Location

Investigational Site Number : 0360006

Richmond, Victoria, 3121, Australia

Location

Investigational Site Number : 0560003

Antwerp, 2060, Belgium

Location

Investigational Site Number : 0560002

Brussels, 1090, Belgium

Location

Investigational Site Number : 0560004

Ghent, 9000, Belgium

Location

Investigational Site Number : 0560001

Leuven, 3000, Belgium

Location

Investigational Site Number : 1240001

Montreal, Quebec, H1T 2M4, Canada

Location

Investigational Site Number : 1240004

Montreal, Quebec, H4A 3J1, Canada

Location

Investigational Site Number : 1240005

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Investigational Site Number : 2030005

Brno, 62500, Czechia

Location

Investigational Site Number : 2030004

Hradec Králové, 50005, Czechia

Location

Investigational Site Number : 2030001

Olomouc, 77900, Czechia

Location

Investigational Site Number : 2030002

Ostrava - Poruba, 70852, Czechia

Location

Investigational Site Number : 2030003

Prague, 12808, Czechia

Location

Investigational Site Number : 2080002

Aalborg, 9100, Denmark

Location

Investigational Site Number : 2500021

Bayonne, 64100, France

Location

Investigational Site Number : 2500008

Caen, 14033, France

Location

Investigational Site Number : 2500009

Dijon, 21000, France

Location

Investigational Site Number : 2500017

Grenoble, 38043, France

Location

Investigational Site Number : 2500013

La Roche-sur-Yon, 85925, France

Location

Investigational Site Number : 2500003

Lille, 59037, France

Location

Investigational Site Number : 2500023

Limoges, 87042, France

Location

Investigational Site Number : 2500019

Montpellier, 34295, France

Location

Investigational Site Number : 2500002

Nantes, 44093, France

Location

Investigational Site Number : 2500015

Paris, 75005, France

Location

Investigational Site Number : 2500016

Paris, 75743, France

Location

Investigational Site Number : 2500005

Pessac, 33600, France

Location

Investigational Site Number : 2500004

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500007

Poitiers, 86021, France

Location

Investigational Site Number : 2500025

Reims, 51092, France

Location

Investigational Site Number : 2500014

Rennes, 35033, France

Location

Investigational Site Number : 2500001

Toulouse, 31059, France

Location

Investigational Site Number : 2500012

Tours, 37044, France

Location

Investigational Site Number : 2500018

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number : 2760001

Leipzig, 04103, Germany

Location

Investigational Site Number : 3000002

Athens, 106 76, Greece

Location

Investigational Site Number : 3000005

Athens, 11527, Greece

Location

Investigational Site Number : 3000001

Athens, 11528, Greece

Location

Investigational Site Number : 3000004

Pátrai, 26504, Greece

Location

Investigational Site Number : 3000003

Thessaloniki, 57010, Greece

Location

Investigational Site Number : 3480001

Budapest, 1083, Hungary

Location

Investigational Site Number : 3480003

Budapest, 1097, Hungary

Location

Investigational Site Number : 3480002

Debrecen, 4032, Hungary

Location

Investigational Site Number : 3800001

Bologna, 40138, Italy

Location

Investigational Site Number : 3800010

Catania, 95123, Italy

Location

Investigational Site Number : 3800009

Florence, 50134, Italy

Location

Investigational Site Number : 3800008

Genova, 16132, Italy

Location

Investigational Site Number : 3800007

Milan, 20132, Italy

Location

Investigational Site Number : 3800002

Milan, 20133, Italy

Location

Investigational Site Number : 3800006

Padua, 35128, Italy

Location

Investigational Site Number : 3800004

Terni, 05100, Italy

Location

Investigational Site Number : 3800003

Torino, 10126, Italy

Location

Investigational Site Number : 3920001

Nagoya, Aichi-ken, 467-8602, Japan

Location

Investigational Site Number : 3920005

Shibukawa-shi, Gunma, 377-0280, Japan

Location

Investigational Site Number : 3920004

Sapporo, Hokkaido, 060-8543, Japan

Location

Investigational Site Number : 3920006

Kyoto, Kyoto, 603-8151, Japan

Location

Investigational Site Number : 3920008

Suwa-shi, Nagano, 392-8510, Japan

Location

Investigational Site Number : 3920003

Okayama, Okayama-ken, 701-1192, Japan

Location

Investigational Site Number : 3920007

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Investigational Site Number : 3920002

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Investigational Site Number : 5540001

Takapuna, Auckland, 1309, New Zealand

Location

Investigational Site Number : 5540004

Dunedin, Otago, 9016, New Zealand

Location

Investigational Site Number : 5540003

Hamilton, Waikato Region, 3204, New Zealand

Location

Investigational Site Number : 5540002

Auckland, 2025, New Zealand

Location

Investigational Site Number : 5780001

Oslo, 0450, Norway

Location

Investigational Site Number : 6160005

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Investigational Site Number : 6160003

Lublin, Lubusz Voivodeship, 20-081, Poland

Location

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

Investigational Site Number : 6160002

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Investigational Site Number : 6200004

Coimbra, 3000-075, Portugal

Location

Investigational Site Number : 6200002

Lisbon, 1070, Portugal

Location

Investigational Site Number : 6200001

Porto, 4200, Portugal

Location

Investigational Site Number : 6430004

Moscow, 125167, Russia

Location

Investigational Site Number : 6430001

Moscow, 125284, Russia

Location

Investigational Site Number : 6430002

Moscow, 129301, Russia

Location

Investigational Site Number : 7030001

Bratislava, 83310, Slovakia

Location

Investigational Site Number : 4100007

Hwasun-gun, Jeollanam-do, 58128, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 06351, South Korea

Location

Investigational Site Number : 4100006

Incheon, 21565, South Korea

Location

Investigational Site Number : 4100005

Seoul, 06591, South Korea

Location

Investigational Site Number : 7240005

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

Location

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240006

Santander, Cantabria, 39008, Spain

Location

Investigational Site Number : 7240002

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number : 7240003

Madrid, 28006, Spain

Location

Investigational Site Number : 7240004

Salamanca, 37007, Spain

Location

Investigational Site Number : 7520004

Luleå, 97180, Sweden

Location

Investigational Site Number : 7520005

Uddevalla, 451 80, Sweden

Location

Investigational Site Number : 1580004

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number : 1580002

Taichung, 40447, Taiwan

Location

Investigational Site Number : 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number : 1580003

Taoyuan District, 333, Taiwan

Location

Investigational Site Number : 7920001

Ankara, 06620, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Antalya, 07050, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Istanbul, 34010, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Istanbul, 34381, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, 34390, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Istanbul, Turkey (Türkiye)

Location

Investigational Site Number : 7920008

Izmir, 35040, Turkey (Türkiye)

Location

Investigational Site Number : 7920010

Izmir, 35340, Turkey (Türkiye)

Location

Investigational Site Number : 7920009

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Kocaeli, 41400, Turkey (Türkiye)

Location

Investigational Site Number : 8260002

London, London, City of, EC1A 7BE, United Kingdom

Location

Investigational Site Number : 8260003

London, London, City of, SE1 9RT, United Kingdom

Location

Investigational Site Number : 8260001

London, London, City of, WC1E6AG, United Kingdom

Location

Related Publications (8)

• Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14.

  PMID: 31735560 BACKGROUND

• Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10.

  PMID: 35151415 BACKGROUND

• Richardson PG, Perrot A, Miguel JS, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang SY, Minarik J, Cavo M, Prince HM, Mace S, Zhang R, Dubin F, Morisse MC, Anderson KC. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis. Haematologica. 2024 Jul 1;109(7):2239-2249. doi: 10.3324/haematol.2023.284325.

  PMID: 38299578 DERIVED

• Beksac M, Spicka I, Hajek R, Bringhen S, Jelinek T, Martin T, Mikala G, Moreau P, Symeonidis A, Rawlings AM, van de Velde H, Richardson PG. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022 Nov;122:106948. doi: 10.1016/j.leukres.2022.106948. Epub 2022 Sep 6.

  PMID: 36108425 DERIVED

• Sunami K, Ikeda T, Huang SY, Wang MC, Koh Y, Min CK, Yeh SP, Matsumoto M, Uchiyama M, Iyama S, Shimazaki C, Lee JH, Kim K, Kaneko H, Kim JS, Lin TL, Campana F, Tada K, Iida S, Suzuki K; ICARIA-MM study group. Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e751-e761. doi: 10.1016/j.clml.2022.04.005. Epub 2022 Apr 8.

  PMID: 35641409 DERIVED

• Wilmoth J, Colson K, Dubin F, Kellam C. Isatuximab: Nursing Considerations for Use in the Treatment of Multiple Myeloma. Clin J Oncol Nurs. 2021 Dec 1;25(6):706-712. doi: 10.1188/21.CJON.706-712.

  PMID: 34800109 DERIVED

• Bringhen S, Pour L, Vorobyev V, Vural F, Warzocha K, Benboubker L, Koh Y, Maisnar V, Karlin L, Pavic M, Campana F, Le Guennec S, Menas F, van de Velde H, Richardson PG. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.

  PMID: 33839618 DERIVED

• Schjesvold FH, Richardson PG, Facon T, Alegre A, Spencer A, Jurczyszyn A, Sunami K, Frenzel L, Min CK, Guillonneau S, Lin PL, Le-Guennec S, Campana F, van de Velde H, Bensfia S, Bringhen S. Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis. Haematologica. 2021 Apr 1;106(4):1182-1187. doi: 10.3324/haematol.2020.253450. No abstract available.

  PMID: 32586908 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 13, 2016
• Study Start: December 22, 2016
• Primary Completion: November 22, 2018
• Study Completion: November 1, 2023
• Last Updated: January 17, 2025
• Results First Posted: December 6, 2019

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (10); AU (5); ES (6); NO (1); IT (9); JP (8); CZ (5); NZ (4); DK (1); RU (3); PT (3); US (2); GB (3); TW (4); DE (1); KR (5); CA (3); GR (5); BE (4); HU (3); SL (1); PL (4); SE (2); FR (19)