Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

NCT01335399 | Completed Phase 3 Results DMC

• 2 other identifiers: CA204-0062010-022445-20
• Study Type: interventional
• Target: 748
• Locations: 19 countries
• Sites: 231

Brief Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

Conditions

Multiple Myeloma

Keywords

Newly Diagnosed; Previously Untreated

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization

  From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  From randomization to primary completion date (approximately 8 years)

• Overall Survival (OS)

  From randomization to the date of death (up to 8 years)

• Mean Change From Baseline of Pain Severity Score and Pain Interference Score

  From Baseline to End of Treatment (approximately 8 years)

• Progression Free Survival (PFS) Rate at Specific Time-points

  From randomization to the specified time-point (up to 5 years)

Study Arms (2)

Lenalidomide + Dexamethasone

ACTIVE COMPARATOR

Drug: Lenalidomide; Drug: Dexamethasone

Lenalidomide + Dexamethasone + Elotuzumab

EXPERIMENTAL

Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63)

Interventions

Lenalidomide DRUG

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Also known as: Revlimid®

Lenalidomide + Dexamethasone; Lenalidomide + Dexamethasone + Elotuzumab

Dexamethasone DRUG

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Also known as: Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

Lenalidomide + Dexamethasone

Elotuzumab (BMS-901608; HuLuc63) BIOLOGICAL

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Lenalidomide + Dexamethasone + Elotuzumab

Eligibility Criteria

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

You may qualify if:

• Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
• have not received any prior systemic anti-myeloma therapy AND
• have measurable disease AND
• are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old

You may not qualify if:

• Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
• Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Active plasma cell leukemia
• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• AbbVie: collaborator

Study Sites (235)

Local Institution - 1628

Birmingham, Alabama, 35243, United States

Location

Local Institution - 7619

Mobile, Alabama, 36604, United States

Location

Local Institution - 7618

Mobile, Alabama, 36608, United States

Location

Local Institution - 7617

Chandler, Arizona, 85224, United States

Location

Local Institution - 1644

Tucson, Arizona, 85715, United States

Location

Local Institution - 1618

Bakersfield, California, 93309, United States

Location

Local Institution - 1602

Berkeley, California, 94704, United States

Location

Local Institution - 1636

Corona, California, 92879, United States

Location

Local Institution - 1668

Corona, California, 92879, United States

Location

Local Institution - 1616

Greenbrae, California, 94904, United States

Location

Local Institution - 7609

Long Beach, California, 90813, United States

Location

Local Institution - 1660

Los Angeles, California, 90095, United States

Location

Local Institution - 1673

Orange, California, 92868, United States

Location

Local Institution - 1613

San Diego, California, 92123, United States

Location

Local Institution - 1621

New Haven, Connecticut, 06520, United States

Location

Local Institution - 1612

Washington D.C., District of Columbia, 20010, United States

Location

Local Institution - 1682

Boca Raton, Florida, 33486, United States

Location

Local Institution - 1617

Brooksville, Florida, 34613, United States

Location

Local Institution - 1648

Fort Myers, Florida, 33916, United States

Location

Local Institution - 7613

Hollywood, Florida, 33021, United States

Location

Local Institution - 1623

Jacksonville, Florida, 32256, United States

Location

Local Institution - 1625

New Port Richey, Florida, 34652, United States

Location

Local Institution - 1649

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 1611

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 1630

Atlanta, Georgia, 30322, United States

Location

Local Institution - 1684

Honolulu, Hawaii, 96819, United States

Location

Local Institution - 1607

Chicago, Illinois, 19123, United States

Location

Local Institution - 1635

Chicago, Illinois, 60612, United States

Location

Local Institution - 1632

Maywood, Illinois, 60153, United States

Location

Local Institution - 7606

Peoria, Illinois, 61615, United States

Location

Local Institution - 7610

Skokie, Illinois, 60077, United States

Location

Local Institution - 1603

Urbana, Illinois, 61801, United States

Location

Local Institution - 7616

Bloomington, Indiana, 47403, United States

Location

Local Institution - 7620

Indianapolis, Indiana, 46237, United States

Location

Local Institution - 1669

Indianapolis, Indiana, 46260, United States

Location

Local Institution - 1656

Mishawaka, Indiana, 46545, United States

Location

Local Institution - 1633

Iowa City, Iowa, 52242, United States

Location

Local Institution - 1674

Lexington, Kentucky, 40503, United States

Location

Local Institution - 1683

Louisville, Kentucky, 40207, United States

Location

Local Institution - 1646

Lafayette, Louisiana, 70503, United States

Location

Local Institution - 7614

Marrero, Louisiana, 70072, United States

Location

Local Institution - 1626

New Orleans, Louisiana, 70121, United States

Location

Local Institution - 1652

Shreveport, Louisiana, 71103, United States

Location

Local Institution - 1676

Baltimore, Maryland, 21204, United States

Location

Local Institution - 1650

Baltimore, Maryland, 21237, United States

Location

Local Institution - 1619

Boston, Massachusetts, 02215, United States

Location

Local Institution - 1699

Boston, Massachusetts, 02215, United States

Location

Local Institution - 1604

Detroit, Michigan, 48202, United States

Location

Local Institution - 1667

Jefferson City, Missouri, 65101, United States

Location

Local Institution - 1651

Springfield, Missouri, 65804, United States

Location

Local Institution - 1645

St Louis, Missouri, 63110, United States

Location

Local Institution - 1637

Omaha, Nebraska, 68198-7680, United States

Location

Local Institution - 7621

Mineola, New York, 11501, United States

Location

Local Institution - 1615

New York, New York, 10019, United States

Location

Local Institution - 1671

Stony Brook, New York, 11794-8183, United States

Location

Local Institution - 7604

Goldsboro, North Carolina, 27534, United States

Location

Local Institution - 1610

Winston-Salem, North Carolina, 27103, United States

Location

Local Institution - 1608

Cleveland, Ohio, 44195, United States

Location

Local Institution - 1693

Cleveland, Ohio, 44195, United States

Location

Local Institution - 1638

Columbus, Ohio, 43210, United States

Location

Local Institution - 1664

Columbus, Ohio, 43219, United States

Location

Local Institution - 1690

Middletown, Ohio, 45042, United States

Location

Local Institution - 1655

Tulsa, Oklahoma, 74146, United States

Location

Local Institution - 7611

Langhorne, Pennsylvania, 19047, United States

Location

Local Institution - 1647

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 1679

Pittsburgh, Pennsylvania, 15240, United States

Location

Local Institution - 1677

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 1629

Charleston, South Carolina, 29414, United States

Location

Local Institution - 7615

Charleston, South Carolina, 29425, United States

Location

Local Institution - 1624

Greenville, South Carolina, 29615, United States

Location

Local Institution - 7607

Sioux Falls, South Dakota, 57105, United States

Location

Local Institution - 1600

Knoxville, Tennessee, 37909, United States

Location

Local Institution - 7628

Memphis, Tennessee, 38120, United States

Location

Local Institution - 1627

Nashville, Tennessee, 37203, United States

Location

Local Institution - 1670

Nashville, Tennessee, 37232-5505, United States

Location

Local Institution - 1634

Corpus Christi, Texas, 78412, United States

Location

Local Institution - 7612

Dallas, Texas, 75246, United States

Location

Local Institution - 1643

Houston, Texas, 77030, United States

Location

Local Institution - 1686

Houston, Texas, 77030, United States

Location

Local Institution - 1642

Houston, Texas, 77090, United States

Location

Local Institution - 7623

Ogden, Utah, 84405, United States

Location

Local Institution - 1657

Fredericksburg, Virginia, 22408, United States

Location

Local Institution - 1640

Seattle, Washington, 98108, United States

Location

Local Institution - 1631

Seattle, Washington, 98109, United States

Location

Local Institution - 1601

Huntington, West Virginia, 25701, United States

Location

Gundersen Clinic, Ltd

La Crosse, Wisconsin, 54601, United States

Location

Local Institution - 1663

Madison, Wisconsin, 53717, United States

Location

Local Institution - 1609

Madison, Wisconsin, 53792, United States

Location

Local Institution - 3600

Garran, Australian Capital Territory, 2605, Australia

Location

Local Institution - 3607

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 3610

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 3609

Herston, Queensland, 4029, Australia

Location

Local Institution - 3608

Milton, Queensland, 4064, Australia

Location

Local Institution - 3612

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 3606

Woodville South, South Australia, 5001, Australia

Location

Local Institution - 3601

Fitzroy, Victoria, 3065, Australia

Location

Local Institution - 3602

Frankston, Victoria, 3199, Australia

Location

Local Institution - 3603

Heidelberg Melbourne, Victoria, 3084, Australia

Location

Local Institution - 3604

Wodonga, Victoria, 3690, Australia

Location

Local Institution - 3605

Murdoch, 6150, Australia

Location

Local Institution - 3611

Nedlands, 6009, Australia

Location

Local Institution - 4052

Fadingerstraße 1, 4020, Austria

Location

Local Institution - 4051

Innsbruck, 6020, Austria

Location

Local Institution - 4054

Rankweil, 6830, Austria

Location

Local Institution - 4053

Wels, 4600, Austria

Location

Local Institution - 4160

Brussels, 1020, Belgium

Location

Local Institution - 4156

Brussels, 1090, Belgium

Location

Local Institution - 4157

Brussles, 1200, Belgium

Location

Local Institution - 4154

Charleroi, 6000, Belgium

Location

Local Institution - 4159

Haine-Saint-Paul, 7100, Belgium

Location

Local Institution - 4158

Leuven, 3000, Belgium

Location

Local Institution - 4150

Liège, 4000, Belgium

Location

Local Institution - 4153

Roeselare, 8800, Belgium

Location

Local Institution - 4151

Yvoir, 5530, Belgium

Location

Local Institution - 2601

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 2600

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 2602

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Local Institution - 2611

Saint John, New Brunswick, E2L 4L2, Canada

Location

Local Institution - 2610

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 2606

London, Ontario, N6A 5W9, Canada

Location

Local Institution - 2612

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 2603

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Local Institution - 2605

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 2607

Montreal, Quebec, H3A 1A1, Canada

Location

Local Institution - 4252

Hradec Králové, 500 05, Czechia

Location

Local Institution - 4250

Prague, 100 34, Czechia

Location

Local Institution - 4251

Prague, 128 08, Czechia

Location

Local Institution - 4565

Aschaffenburg, 63739, Germany

Location

Local Institution - 4550

Berlin, 12200, Germany

Location

Local Institution - 4555

Chemnitz, 09113, Germany

Location

Local Institution - 4563

Cologne, 50937, Germany

Location

Local Institution - 4562

Dresden, 01307, Germany

Location

Local Institution - 4552

Hamm, 59063, Germany

Location

Local Institution - 4553

Heidelberg, 69120, Germany

Location

Local Institution - 4560

Jena, 07747, Germany

Location

Local Institution - 4554

Mainz, 55101, Germany

Location

Local Institution - 4561

München, 81377, Germany

Location

Local Institution - 4558

Münster, 48149, Germany

Location

Local Institution - 4551

Offenbach, 63069, Germany

Location

Local Institution - 4556

Stuttgart, 70376, Germany

Location

Local Institution - 4564

Tübingen, 72076, Germany

Location

Local Institution - 4559

Ulm, 89081, Germany

Location

Local Institution - 4653

Athens, 11527, Greece

Location

Local Institution - 4651

Athens, 11528, Greece

Location

Local Institution - 4650

Ioannina, 45500, Greece

Location

Local Institution - 4652

Larissa, 41110, Greece

Location

Local Institution - 4654

Pátrai, 26504, Greece

Location

Local Institution - 4751

Budapest, 1097, Hungary

Location

Local Institution - 4754

Budapest, 1122, Hungary

Location

Local Institution - 4750

Debrecen, 4012, Hungary

Location

Local Institution - 4753

Győr, 9024, Hungary

Location

Local Institution - 4752

Szeged, 6720, Hungary

Location

Local Institution - 4852

Dublin, 7, Ireland

Location

Local Institution - 4850

Dublin, 8, Ireland

Location

Local Institution - 4851

Galway, 0, Ireland

Location

Local Institution - 4950

Afula, 1834111, Israel

Location

Local Institution - 4956

Ashkelon, 7830604, Israel

Location

Local Institution - 4960

Haifa, 3109601, Israel

Location

Local Institution - 4958

Jerusalem, 91031, Israel

Location

Local Institution - 4951

Jerusalem, 91120, Israel

Location

Local Institution - 4959

Kfar Saba, 4428164, Israel

Location

Local Institution - 4954

Nahariya, 2210001, Israel

Location

Local Institution - 4952

Petah Tikva, 4941492, Israel

Location

Local Institution - 4957

Tel Aviv, 64239, Israel

Location

Local Institution - 4955

Ẕerifin, 70300, Israel

Location

Local Institution - 5067

Ancona, 60126, Italy

Location

Local Institution - 5065

Bari, 70124, Italy

Location

Local Institution - 5053

Bergamo, 24127, Italy

Location

Local Institution - 5070

Bologna, 40138, Italy

Location

Local Institution - 5066

Florence, 50134, Italy

Location

Local Institution - 5050

Genova, 16132, Italy

Location

Local Institution - 5057

Meldola, 47014, Italy

Location

Local Institution - 5069

Milan, 20132, Italy

Location

Local Institution - 5075

Milan, 20122, Italy

Location

Local Institution - 5052

Monza, 20052, Italy

Location

Local Institution - 5062

Napoli, 80131, Italy

Location

Local Institution - 5068

Napoli, 80131, Italy

Location

Local Institution - 5055

Palermo, 90146, Italy

Location

Local Institution - 5063

Ravenna, 48100, Italy

Location

Local Institution - 5073

Reggio Nell Emilia (RE), 42100, Italy

Location

Local Institution - 5064

Rimini, 47923, Italy

Location

Local Institution - 5058

Roma, 00144, Italy

Location

Local Institution - 5054

Roma, 00168, Italy

Location

Local Institution - 5056

Rome, 00161, Italy

Location

Local Institution - 5072

Terni, 05100, Italy

Location

Local Institution - 5051

Torino, 10126, Italy

Location

Local Institution - 5250

Bialystok, 15-276, Poland

Location

Local Institution - 5252

Chorzów, 41-500, Poland

Location

Local Institution - 5254

Gdansk, 80-952, Poland

Location

Local Institution - 7626

Krakow, 31-531, Poland

Location

Local Institution - 5258

Lodz, 93-510, Poland

Location

Local Institution - 5257

Lublin, 20-081, Poland

Location

Local Institution - 5259

Poznan, 60-569, Poland

Location

Local Institution - 5255

Szczecin, 70-111, Poland

Location

Local Institution - 5256

Warsaw, 02-106, Poland

Location

Local Institution - 5253

Warsaw, 02-507, Poland

Location

Local Institution - 5260

Warsaw, 02-776, Poland

Location

Local Institution - 5251

Wroclaw, 50-367, Poland

Location

Local Institution - 7600

Ponce, 00716, Puerto Rico

Location

Local Institution - 7602

San Juan, 00918, Puerto Rico

Location

Local Institution - 5356

Brasov, 500152, Romania

Location

Local Institution - 5350

Bucaresti, 030171, Romania

Location

Local Institution - 5355

Bucharest, 020125, Romania

Location

Local Institution - 5353

Bucharest, 050098, Romania

Location

Local Institution - 5352

Bucharest, 22328, Romania

Location

Local Institution - 5351

Lasi, 700483, Romania

Location

Local Institution - 5450

Saint Petersburg, 197022, Russia

Location

Local Institution - 5452

Saint Petersburg, 197022, Russia

Location

Local Institution - 5453

Samara, 443095, Russia

Location

Local Institution - 5552

Badalona-barcelona, 08916, Spain

Location

Local Institution - 5559

Barcelona, 08036, Spain

Location

Local Institution - 5555

Barcelona, 08041, Spain

Location

Local Institution - 5557

Donostia / San Sebastian, 20014, Spain

Location

Local Institution - 5561

La Laguna- Tenerife, 38320, Spain

Location

Local Institution - 5553

Madrid, 28006, Spain

Location

Local Institution - 5551

Madrid, 28007, Spain

Location

Local Institution - 5560

Madrid, 28034, Spain

Location

Local Institution - 5554

Madrid, 28041, Spain

Location

Local Institution - 5558

Pamplona, 31008, Spain

Location

Local Institution - 5550

Salamanca, 37007, Spain

Location

Local Institution - 5556

Toledo, 45004, Spain

Location

Local Institution - 5751

Bern, 3010, Switzerland

Location

Local Institution - 5750

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 5753

Zurich, 8028, Switzerland

Location

Local Institution - 5752

Zurich, 8091, Switzerland

Location

Local Institution - 5853

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Local Institution - 5851

Ankara, Dikimevi, 06620, Turkey (Türkiye)

Location

Local Institution - 5854

Izmir, Inciralti, 35340, Turkey (Türkiye)

Location

Local Institution - 5856

Gaziantep, 27310, Turkey (Türkiye)

Location

Local Institution - 5951

Belfast, Antrim, BT9 7AB, United Kingdom

Location

Local Institution - 5953

London, Greater London, SE5 9RS, United Kingdom

Location

Local Institution - 5950

London, EC1A 7BE, United Kingdom

Location

Local Institution - 5954

London, HA1 3UJ, United Kingdom

Location

Local Institution - 5952

London, NW1 2PG, United Kingdom

Location

Local Institution - 5955

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.

  PMID: 35550060 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone; Calcium Dobesilate; elotuzumab

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  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: April 13, 2011
• First Posted: April 14, 2011
• Study Start: August 4, 2011
• Primary Completion: October 1, 2019
• Study Completion: September 3, 2021
• Last Updated: September 30, 2022
• Results First Posted: October 22, 2020

Record last verified: 2022-09

Locations

BE (9); IL (10); CA (10); AU (13); CZ (3); DE (15); GR (5); IT (21); PR (2); RU (3); ES (12); CH (4); TU (4); RO (6); HU (5); IE (3); PL (12); GB (6); US (88)