A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
NCT ID: NCT03682536
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
363 participants
INTERVENTIONAL
2019-01-02
2027-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Luspatercept
Luspatercept
Specified dose on specified days
Epoetin alfa
Epoetin alfa
Specified dose on specified days
Interventions
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Luspatercept
Specified dose on specified days
Epoetin alfa
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Endogenous serum erythropoietin (sEPO) level of \< 500 U/L
* Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
Exclusion Criteria
* Known history of diagnosis of Acute myeloid leukemia (AML)
* Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
18 Years
ALL
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 107
Berkeley, California, United States
Local Institution - 115
San Diego, California, United States
Local Institution - 101
Whittier, California, United States
Local Institution - 104
New Haven, Connecticut, United States
Local Institution - 136
Washington D.C., District of Columbia, United States
Local Institution - 119
Hudson, Florida, United States
Local Institution - 120
St. Petersburg, Florida, United States
Local Institution - 122
Tallahassee, Florida, United States
Local Institution - 108
Tampa, Florida, United States
Local Institution - 118
West Palm Beach, Florida, United States
Local Institution - 102
Paducah, Kentucky, United States
Local Institution - 123
Bethesda, Maryland, United States
Local Institution - 117
Kansas City, Missouri, United States
Local Institution - 134
East Brunswick, New Jersey, United States
Local Institution - 113
Hackensack, New Jersey, United States
Local Institution - 105
Greenville, North Carolina, United States
Local Institution - 131
Portland, Oregon, United States
Univ of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Local Institution - 111
Rock Hill, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Local Institution - 109
Houston, Texas, United States
Local Institution - 114
Salt Lake City, Utah, United States
Local Institution - 132
Charlottesville, Virginia, United States
Local Institution - 127
Chesapeake, Virginia, United States
Local Institution - 206
Albury, New South Wales, Australia
Local Institution - 213
Blacktown, New South Wales, Australia
Local Institution - 200
Concord, New South Wales, Australia
Local Institution - 215
Kogarah, New South Wales, Australia
Local Institution - 211
Nowra, New South Wales, Australia
Local Institution - 210
Waratah, New South Wales, Australia
Local Institution - 207
Wollongong, New South Wales, Australia
Local Institution - 208
Auchenflower, Queensland, Australia
Local Institution - 202
Adelaide, South Australia, Australia
Local Institution - 204
Clayton, Victoria, Australia
Local Institution - 203
Malvern, Victoria, Australia
Local Institution - 209
Melbourne, Victoria, Australia
Local Institution - 205
West Perth, Western Australia, Australia
Local Institution - 212
Randwick, , Australia
Local Institution - 442
Linz, , Austria
Local Institution - 441
Vienna, , Austria
Local Institution - 475
Antwerp, , Belgium
Local Institution - 471
Brasschaat, , Belgium
Local Institution - 474
Brussels, , Belgium
Local Institution - 472
Charleroi, , Belgium
Local Institution - 473
Kortrijk, , Belgium
Local Institution - 470
Leuven, , Belgium
Local Institution - 476
Roeselare, , Belgium
Local Institution - 147
Calgary, Alberta, Canada
Local Institution - 145
Edmonton, Alberta, Canada
Local Institution - 142
Hamilton, Ontario, Canada
Local Institution - 140
Ottawa, Ontario, Canada
Local Institution - 141
Toronto, Ontario, Canada
Local Institution - 144
Montreal, Quebec, Canada
Local Institution - 148
Montreal, Quebec, Canada
Local Institution - 151
Saskatoon, Saskatchewan, Canada
Local Institution - 152
Sherbrooke, , Canada
Local Institution - 560
Hradec Králové, , Czechia
Local Institution - 564
Ostrava-Poruba, , Czechia
Local Institution - 563
Prague, , Czechia
Local Institution - 562
Prague, , Czechia
Local Institution - 561
Prague, , Czechia
Local Institution - 317
Angers, , France
Local Institution - 312
Bayonne, , France
Local Institution - 311
Caen, , France
Local Institution - 306
La Tronche, , France
Local Institution - 305
Le Mans, , France
Local Institution - 309
Lille, , France
Local Institution - 303
Limoges, , France
Local Institution - 307
Nantes, , France
Local Institution - 301
Nice, , France
Local Institution - 302
Paris, , France
Local Institution - 313
Paris, , France
Local Institution - 308
Pessac, , France
Local Institution - 315
Pierre-Bénite, , France
Local Institution - 316
Poitiers, , France
Local Institution - 314
Strasbourg, , France
Local Institution - 300
Toulouse, , France
Local Institution - 310
Tours, , France
Local Institution - 304
Vandœuvre-lès-Nancy, , France
Local Institution - 422
Baden-Warttemberg, , Germany
Local Institution - 424
Berlin, , Germany
Local Institution - 428
Cologne, , Germany
Local Institution - 426
Dresden, , Germany
Local Institution - 429
Duisburg, , Germany
Local Institution - 420
Düsseldorf, , Germany
Local Institution - 431
Hamburg, , Germany
Local Institution - 435
Keil, , Germany
Local Institution - 423
Koblenz, , Germany
Local Institution - 430
Leipzig, , Germany
Local Institution - 436
Mannheim, , Germany
Local Institution - 421
München, , Germany
Local Institution - 425
Winnenden, , Germany
Local Institution - 427
Würzburg, , Germany
Local Institution - 389
Heraklion, Irakleio, Greece
Local Institution - 396
Alexandroupoli, , Greece
Local Institution - 397
Athens, , Greece
Local Institution - 391
Athens, , Greece
Local Institution - 395
Athens, , Greece
Local Institution - 392
Athens, , Greece
Local Institution - 398
Pátrai, , Greece
Local Institution - 393
Rio Patras, , Greece
Local Institution - 399
Thessaloniki, , Greece
Local Institution - 390
Thessaloniki, , Greece
Local Institution - 535
Budapest, , Hungary
Local Institution - 534
Debrecen, , Hungary
Local Institution - 536
Nyíregyháza, , Hungary
Local Institution - 386
Haifa, , Israel
Local Institution - 383
Jerusalem, , Israel
Local Institution - 384
Jerusalem, , Israel
Local Institution - 381
Kfar Saba, , Israel
Local Institution - 385
Nahariya, , Israel
Local Institution - 382
Tel Aviv, , Israel
Local Institution - 380
Ẕerifin, , Israel
Local Institution - 331
Orbassano, TO, Italy
Local Institution - 324
Bologna, , Italy
Local Institution - 327
Florence, , Italy
Local Institution - 330
Meldola, , Italy
Local Institution - 321
Milan, , Italy
Local Institution - 329
Padua, , Italy
Local Institution - 326
Reggio Calabria, , Italy
Local Institution - 328
Roma, , Italy
Local Institution - 332
Roma, , Italy
Local Institution - 325
Rome, , Italy
Local Institution - 323
Rozzano, , Italy
Local Institution - 322
Udine, , Italy
Local Institution - 238
Matsuyama, Ehime, Japan
Local Institution - 244
Nagasaki, Nagasaki, Japan
Local Institution - 236
Sayama, Osaka, Japan
Local Institution - 247
Amagasaki-Shi, , Japan
Local Institution - 249
Fujisawa-Shi, , Japan
Local Institution - 234
Fukuoka, , Japan
Local Institution - 237
Hitachi, Ibaraki, , Japan
Local Institution - 231
Kamogawa, , Japan
Local Institution - 248
Kitakyushu-Shi, , Japan
Local Institution - 270
Nagaoka-Shi, , Japan
Local Institution - 243
Nagoya, , Japan
Local Institution - 235
Okayama, , Japan
Local Institution - 242
Osaka, , Japan
Local Institution - 241
Ōgaki, , Japan
Local Institution - 233
Sagamihara, , Japan
Local Institution - 246
Sapporo, , Japan
Local Institution - 239
Sendai, , Japan
Local Institution - 232
Shibuya-ku, , Japan
Local Institution - 245
Shimotsuga-gun, , Japan
Local Institution - 230
Shinagawa-ku, Tokyo, , Japan
Local Institution - 540
Kaunas, , Lithuania
Local Institution - 541
Vilnius, , Lithuania
Local Institution - 462
Amsterdam, , Netherlands
Local Institution - 464
Nijmegen, , Netherlands
Local Institution - 460
Rotterdam, , Netherlands
Local Institution - 463
Sittard-Geleen, , Netherlands
Local Institution - 461
The Hague, , Netherlands
Local Institution - 570
Lodz, Lódzkie, Poland
Local Institution - 575
Gdansk, , Poland
Local Institution - 572
Lubin, , Poland
Local Institution - 576
Poznan, , Poland
Local Institution - 573
Rzwszow, , Poland
Local Institution - 579
Słupsk, , Poland
Local Institution - 578
Wałbrzych, , Poland
Local Institution - 577
Wroclaw, , Poland
Local Institution - 571
Wroclaw, , Poland
Local Institution - 373
Beja, , Portugal
Local Institution - 371
Braga, , Portugal
Local Institution - 372
Lisbon, , Portugal
Local Institution - 370
Porto, , Portugal
Local Institution - 374
Setúbal, , Portugal
Local Institution - 511
Kaluga, , Russia
Local Institution - 505
Kirov, , Russia
Local Institution - 509
Krasnoyarsk, , Russia
Local Institution - 504
Moscow, , Russia
Local Institution - 507
Moscow, , Russia
Local Institution - 500
Moscow, , Russia
Local Institution - 503
Moscow, , Russia
Local Institution - 510
Saint Petersburg, , Russia
Local Institution - 506
Saint Petersburg, , Russia
Local Institution - 508
Saratov, , Russia
Local Institution - 502
Tula, , Russia
Local Institution - 251
Busan, , South Korea
Local Institution - 257
Daegu, , South Korea
Local Institution - 250
Hwasun-Gun, , South Korea
Local Institution - 253
Seongnam-si, , South Korea
Local Institution - 252
Seoul, , South Korea
Local Institution - 256
Seoul, , South Korea
Local Institution - 255
Seoul, , South Korea
Local Institution - 254
Seoul, , South Korea
Local Institution - 358
Barcelona, , Spain
Local Institution - 350
Barcelona, , Spain
Local Institution - 354
Granada, , Spain
Local Institution - 352
Madrid, , Spain
Local Institution - 355
Madrid, , Spain
Local Institution - 353
Málaga, , Spain
Local Institution - 361
Murcia, , Spain
Local Institution - 356
Ourense, , Spain
Local Institution - 363
Oviedo, , Spain
Local Institution - 362
Palma de Mallorca, , Spain
Local Institution - 351
Salamanca, , Spain
Local Institution - 360
Seville, , Spain
Local Institution - 357
Valencia, , Spain
Local Institution - 359
Valencia, , Spain
Local Institution - 550
Gothenburg, , Sweden
Local Institution - 552
Lund, , Sweden
Local Institution - 551
Stockholm, , Sweden
Local Institution - 450
Bern, , Switzerland
Local Institution - 452
Lucerne, , Switzerland
Local Institution - 451
Winterthur, , Switzerland
Local Institution - 220
Changhua City, Changhua, , Taiwan
Local Institution - 222
Niaosong District Kaohsiung City, , Taiwan
Local Institution - 223
Taichung, , Taiwan
Local Institution - 224
Taichung, , Taiwan
Local Institution - 221
Taipei, , Taiwan
Local Institution - 342
Ankara, , Turkey (Türkiye)
Local Institution - 340
Manisa, , Turkey (Türkiye)
Local Institution - 343
Trabzon, , Turkey (Türkiye)
Local Institution - 526
Cherkassy, , Ukraine
Local Institution - 525
Dnipro, , Ukraine
Local Institution - 522
Kyiv, , Ukraine
Local Institution - 520
Lviv, , Ukraine
Local Institution - 523
Mykolaiv, , Ukraine
Local Institution - 521
Ternopil, , Ukraine
Local Institution - 401
Aberdeen, , United Kingdom
Local Institution - 403
Bournemouth, , United Kingdom
Local Institution - 405
Headington, Oxford, , United Kingdom
Local Institution - 407
Lincoln, , United Kingdom
Local Institution - 404
London, , United Kingdom
Local Institution - 400
Manchester, , United Kingdom
Countries
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References
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Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Pozharskaya V, Rose S, Keeperman K, Lai Y, Kalsekar S, Aggarwal B, Miteva D, Valcarcel D, Fenaux P, Shortt J, Della Porta MG, Platzbecker U. Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial. Adv Ther. 2025 Jul;42(7):3576-3589. doi: 10.1007/s12325-025-03208-5. Epub 2025 May 16.
Della Porta MG, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Sep;11(9):e646-e658. doi: 10.1016/S2352-3026(24)00203-5. Epub 2024 Jul 19.
Platzbecker U, Della Porta MG, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Giuseppi AC, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Shetty JK, Hayati S, Vodala S, Prebet T, Degulys A, Paolini S, Cluzeau T, Fenaux P, Garcia-Manero G. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023 Jul 29;402(10399):373-385. doi: 10.1016/S0140-6736(23)00874-7. Epub 2023 Jun 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
Other Identifiers
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U1111-1218-1810
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501485-22
Identifier Type: OTHER
Identifier Source: secondary_id
ACE-536-MDS-002
Identifier Type: -
Identifier Source: org_study_id
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