AzTrials
AzTrials

Myelodysplastic SyndromesPhase 3COMMANDSNCT03682536

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

A Phase 3 study testing Luspatercept and Epoetin alfa in people with Myelodysplastic Syndromes, run by Celgene at 226 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Luspatercept and Epoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
226 sitesin 26 countries
Study dates
2 Jan 2019to 28 Sep 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
  • 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

Who cannot join

  • Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
  • 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
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

226 sites in 26 countries.

226 sites in 26 countries

United States25 sites

  • Local Institution - 107

    Berkeley, California, 94704

  • Local Institution - 123

    Bethesda, Maryland, 20817

  • Local Institution - 132

    Charlottesville, Virginia, 22903

  • Local Institution - 127

    Chesapeake, Virginia, 23320

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Local Institution - 134

    East Brunswick, New Jersey, 08816

  • Local Institution - 105

    Greenville, North Carolina, 27858-4354

  • Local Institution - 113

    Hackensack, New Jersey, 07601

  • Local Institution - 109

    Houston, Texas, 77030

  • Local Institution - 119

    Hudson, Florida, 34667

  • Local Institution - 117

    Kansas City, Missouri, 64132

  • Tennessee Oncology

    Nashville, Tennessee, 37203-1625

  • Local Institution - 104

    New Haven, Connecticut, 06520

  • Local Institution - 102

    Paducah, Kentucky, 42003

  • Univ of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 131

    Portland, Oregon, 97213

  • Local Institution - 111

    Rock Hill, South Carolina, 29732

  • Local Institution - 114

    Salt Lake City, Utah, 84106

  • Local Institution - 115

    San Diego, California, 92123

  • Local Institution - 120

    St. Petersburg, Florida, 33705

  • Local Institution - 122

    Tallahassee, Florida, 32308

  • Local Institution - 108

    Tampa, Florida, 33612

  • Local Institution - 136

    Washington D.C., District of Columbia, 20422

  • Local Institution - 118

    West Palm Beach, Florida, 33401

  • Local Institution - 101

    Whittier, California, 90603

Other trials in United States

Japan20 sites

  • Local Institution - 247

    Amagasaki-Shi, 660-0892

  • Local Institution - 249

    Fujisawa-Shi, 251-0052

  • Local Institution - 234

    Fukuoka, 810-8563

  • Local Institution - 237

    Hitachi, Ibaraki, 317-0077

  • Local Institution - 231

    Kamogawa, 296-8602

  • Local Institution - 248

    Kitakyushu-Shi, 806-0034

  • Local Institution - 238

    Matsuyama, Ehime, 790-8524

  • Local Institution - 270

    Nagaoka-Shi, 940-2108

  • Local Institution - 244

    Nagasaki, Nagasaki, 8528511

  • Local Institution - 243

    Nagoya, 460-0001

  • Local Institution - 241

    Ōgaki, 503-8502

  • Local Institution - 235

    Okayama, 700-8557

  • Local Institution - 242

    Osaka, 545-8586

  • Local Institution - 233

    Sagamihara, 252-0375

  • Local Institution - 246

    Sapporo, 064-0804

  • Local Institution - 236

    Sayama, Osaka, 5898511

  • Local Institution - 239

    Sendai, 980-8574

  • Local Institution - 232

    Shibuya-ku, 150-8935

  • Local Institution - 245

    Shimotsuga-gun, 321-0293

  • Local Institution - 230

    Shinagawa-ku, Tokyo, 141-8625

Other trials in Japan

France18 sites

  • Local Institution - 317

    Angers, 49000

  • Local Institution - 312

    Bayonne, 64109

  • Local Institution - 311

    Caen, 14033

  • Local Institution - 306

    La Tronche, 38700

  • Local Institution - 305

    Le Mans, 72037

  • Local Institution - 309

    Lille, 59037

  • Local Institution - 303

    Limoges, 87042

  • Local Institution - 307

    Nantes, 44093

  • Local Institution - 301

    Nice, 06200

  • Local Institution - 302

    Paris, 75010

  • Local Institution - 313

    Paris, 75014

  • Local Institution - 308

    Pessac, 33604

  • Local Institution - 315

    Pierre-Bénite, 69495

  • Local Institution - 316

    Poitiers, 86021

  • Local Institution - 314

    Strasbourg, 67033

  • Local Institution - 300

    Toulouse, 31059

  • Local Institution - 310

    Tours, 37044

  • Local Institution - 304

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia14 sites

  • Local Institution - 202

    Adelaide, South Australia, 5000

  • Local Institution - 206

    Albury, New South Wales, 2640

  • Local Institution - 208

    Auchenflower, Queensland, 4066

  • Local Institution - 213

    Blacktown, New South Wales, 2148

  • Local Institution - 204

    Clayton, Victoria, 3168

  • Local Institution - 200

    Concord, New South Wales, 2139

  • Local Institution - 215

    Kogarah, New South Wales, 2217

  • Local Institution - 203

    Malvern, Victoria, 3144

  • Local Institution - 209

    Melbourne, Victoria, 3004

  • Local Institution - 211

    Nowra, New South Wales, 2541

  • Local Institution - 212

    Randwick, 2031

  • Local Institution - 210

    Waratah, New South Wales, 2298

  • Local Institution - 205

    West Perth, Western Australia, 6005

  • Local Institution - 207

    Wollongong, New South Wales, 2500

Other trials in Australia

Germany14 sites

  • Local Institution - 422

    Baden-Warttemberg, 73557

  • Local Institution - 424

    Berlin, 14195

  • Local Institution - 428

    Cologne, 50677

  • Local Institution - 426

    Dresden, 01307

  • Local Institution - 429

    Duisburg, 47166

  • Local Institution - 420

    Düsseldorf, 40479

  • Local Institution - 431

    Hamburg, 22081

  • Local Institution - 435

    Keil, 24105

  • Local Institution - 423

    Koblenz, 56068

  • Local Institution - 430

    Leipzig, 04103

  • Local Institution - 436

    Mannheim, 68167

  • Local Institution - 421

    München, 81675

  • Local Institution - 425

    Winnenden, 71364

  • Local Institution - 427

    Würzburg, 97070

Other trials in Germany

Spain14 sites

  • Local Institution - 358

    Barcelona, 08035

  • Local Institution - 350

    Barcelona, 08908

  • Local Institution - 354

    Granada, 18014

  • Local Institution - 352

    Madrid, 28007

  • Local Institution - 355

    Madrid, 28041

  • Local Institution - 353

    Málaga, 29010

  • Local Institution - 361

    Murcia, 30008

  • Local Institution - 356

    Ourense, 32005

  • Local Institution - 363

    Oviedo, 33011

  • Local Institution - 362

    Palma de Mallorca, 7120

  • Local Institution - 351

    Salamanca, 37007

  • Local Institution - 360

    Seville, 41013

  • Local Institution - 357

    Valencia, 46010

  • Local Institution - 359

    Valencia, 46026

Other trials in Spain

Italy12 sites

  • Local Institution - 324

    Bologna, 40138

  • Local Institution - 327

    Florence, 50134

  • Local Institution - 330

    Meldola, 47014

  • Local Institution - 321

    Milan, 20162

  • Local Institution - 331

    Orbassano, TO, 10043

  • Local Institution - 329

    Padova, 35128

  • Local Institution - 326

    Reggio Calabria, 89124

  • Local Institution - 328

    Roma, 00133

  • Local Institution - 332

    Roma, 00189

  • Local Institution - 325

    Rome, 00161

  • Local Institution - 323

    Rozzano, 20089

  • Local Institution - 322

    Udine, 33100

Other trials in Italy

Russia11 sites

  • Local Institution - 511

    Kaluga, 248007

  • Local Institution - 505

    Kirov, 610027

  • Local Institution - 509

    Krasnoyarsk, 660022

  • Local Institution - 504

    Moscow, 111123

  • Local Institution - 507

    Moscow, 123182

  • Local Institution - 500

    Moscow, 125284

  • Local Institution - 503

    Moscow, 129301

  • Local Institution - 510

    Saint Petersburg, 197022

  • Local Institution - 506

    Saint Petersburg, 197341

  • Local Institution - 508

    Saratov, 410012

  • Local Institution - 502

    Tula, 300053

Other trials in Russia

Greece10 sites

  • Local Institution - 396

    Alexandroupoli, 08100

  • Local Institution - 397

    Athens, 10676

  • Local Institution - 391

    Athens, 115 27

  • Local Institution - 395

    Athens, 115 27

  • Local Institution - 392

    Athens, 12464

  • Local Institution - 389

    Heraklion, Irakleio, 71110

  • Local Institution - 398

    Pátrai, 26500

  • Local Institution - 393

    Rio Patras, 26500

  • Local Institution - 399

    Thessaloniki, 546 36

  • Local Institution - 390

    Thessaloniki, 57010

Other trials in Greece

Canada9 sites

  • Local Institution - 147

    Calgary, Alberta, T2N 4N2

  • Local Institution - 145

    Edmonton, Alberta, T6G 2B7

  • Local Institution - 142

    Hamilton, Ontario, L8V 5C2

  • Local Institution - 144

    Montreal, Quebec, H1T 2M4

  • Local Institution - 148

    Montreal, Quebec, H3T 1E2

  • Local Institution - 140

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 151

    Saskatoon, Saskatchewan, S7N 4H4

  • Local Institution - 152

    Sherbrooke, J1H 5N4

  • Local Institution - 141

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Poland9 sites

  • Local Institution - 575

    Gdansk, 80-952

  • Local Institution - 570

    Lodz, Lódzkie, 93-513

  • Local Institution - 572

    Lubin, 20-081

  • Local Institution - 576

    Poznan, 60-569

  • Local Institution - 573

    Rzwszow, 35-055

  • Local Institution - 579

    Słupsk, 76-200

  • Local Institution - 578

    Wałbrzych, 58-309

  • Local Institution - 577

    Wroclaw, 50-367

  • Local Institution - 571

    Wroclaw, 50-556

Other trials in Poland

South Korea8 sites

  • Local Institution - 251

    Busan, 49241

  • Local Institution - 257

    Daegu, 700-721

  • Local Institution - 250

    Hwasun-Gun, 58128

  • Local Institution - 253

    Seongnam-si, 13620

  • Local Institution - 252

    Seoul, 06351

  • Local Institution - 256

    Seoul, 06591

  • Local Institution - 255

    Seoul, 3080

  • Local Institution - 254

    Seoul, 5505

Other trials in South Korea

Belgium7 sites

  • Local Institution - 475

    Antwerp, 2020

  • Local Institution - 471

    Brasschaat, 2930

  • Local Institution - 474

    Brussels, 1200

  • Local Institution - 472

    Charleroi, 6000

  • Local Institution - 473

    Kortrijk, 8500

  • Local Institution - 470

    Leuven, 3000

  • Local Institution - 476

    Roeselare, 8800

Other trials in Belgium

Israel7 sites

  • Local Institution - 386

    Haifa, 34362

  • Local Institution - 383

    Jerusalem, 9103102

  • Local Institution - 384

    Jerusalem, 91120

  • Local Institution - 381

    Kfar Saba, 44281

  • Local Institution - 385

    Nahariya, 22100

  • Local Institution - 382

    Tel Aviv, 64239

  • Local Institution - 380

    Tsrifin, 70300

Other trials in Israel

Ukraine6 sites

  • Local Institution - 526

    Cherkassy, 18009

  • Local Institution - 525

    Dnipro, 49102

  • Local Institution - 522

    Kyiv, 3115

  • Local Institution - 520

    Lviv, 79044

  • Local Institution - 523

    Mykolaiv, 54058

  • Local Institution - 521

    Ternopil, 46002

Other trials in Ukraine

United Kingdom6 sites

  • Local Institution - 401

    Aberdeen, AB25 2ZN

  • Local Institution - 403

    Bournemouth, BH7 7DW

  • Local Institution - 405

    Headington, Oxford, OX3 7LE

  • Local Institution - 407

    Lincoln, LN2 5QY

  • Local Institution - 404

    London, SE5 9RS

  • Local Institution - 400

    Manchester, M20 4BX

Other trials in United Kingdom

Czechia5 sites

  • Local Institution - 560

    Hradec Králové, 500 05

  • Local Institution - 564

    Ostrava-Poruba, 708 52

  • Local Institution - 563

    Prague, 100 34

  • Local Institution - 562

    Prague, 128 08

  • Local Institution - 561

    Prague, 128 20

Other trials in Czechia

Netherlands5 sites

  • Local Institution - 462

    Amsterdam, 1081 HV

  • Local Institution - 464

    Nijmegen, 6525 GA

  • Local Institution - 460

    Rotterdam, 3015 CE

  • Local Institution - 463

    Sittard-Geleen, 6162 BG

  • Local Institution - 461

    The Hague, 2545 CH

Other trials in Netherlands

Portugal5 sites

  • Local Institution - 373

    Beja, 7801-849

  • Local Institution - 371

    Braga, 4710-243

  • Local Institution - 372

    Lisbon, 1099-023

  • Local Institution - 370

    Porto, 4200-072

  • Local Institution - 374

    Setúbal, 2910-446

Other trials in Portugal

Taiwan5 sites

  • Local Institution - 220

    Changhua City, Changhua, 500

  • Local Institution - 222

    Niaosong District Kaohsiung City, 83301

  • Local Institution - 223

    Taichung, 40447

  • Local Institution - 224

    Taichung, 40705

  • Local Institution - 221

    Taipei, 100225

Other trials in Taiwan

Hungary3 sites

  • Local Institution - 535

    Budapest, 1096

  • Local Institution - 534

    Debrecen, 4032

  • Local Institution - 536

    Nyíregyháza, 4400

Other trials in Hungary

Sweden3 sites

  • Local Institution - 550

    Gothenburg, SE-413 45

  • Local Institution - 552

    Lund, SE-221 85

  • Local Institution - 551

    Stockholm, SE-141 86

Other trials in Sweden

Switzerland3 sites

  • Local Institution - 450

    Bern, 3010

  • Local Institution - 452

    Lucerne, 6000

  • Local Institution - 451

    Winterthur, 8400

Other trials in Switzerland

Turkey (Türkiye)3 sites

  • Local Institution - 342

    Ankara, 06100

  • Local Institution - 340

    Manisa, 45030

  • Local Institution - 343

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Austria2 sites

  • Local Institution - 442

    Linz, 4020

  • Local Institution - 441

    Vienna, 1090

Other trials in Austria

Lithuania2 sites

  • Local Institution - 540

    Kaunas, LT-50009

  • Local Institution - 541

    Vilnius, LT-08661

Other trials in Lithuania

About this study

Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Being tested
Luspatercept, Epoetin alfa
Keywords
Luspatercept, ACE-536, Anemia, Myelodysplastic Syndromes, Blood Transfusion, RBC Transfusion, Erythropoiesis-stimulating agents, Erythropoietin, Myelodysplasia, Epoetin alpha
Medical subject headings
Myelodysplastic Syndromes, Anemia, Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LuspaterceptDrug

    Also called ACE-536

    Specified dose on specified days

  • Epoetin alfaDrug

    Also called EPREX®, ERYPO®, PROCRIT®

    Specified dose on specified days

Study groups in NCT03682536
Study groupRoleWhat they receive
LuspaterceptExperimentalNot described
Receives: Drug: Luspatercept
Epoetin alfaActive comparatorNot described
Receives: Drug: Epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL

    Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase ≥ 1.5 g/dL compared to baseline.

    After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated.

    4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion.

    Measured: Week 1 through Week 24

Secondary outcomes (20)

  1. Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks

    Red blood cell transfusion independence (RBC-TI) for 24 weeks is defined as the percentage of participants who did not receive RBC transfusions from Week 1 through Week 24.

    Measured: Week 1 through Week 24

  2. Mean Hemoglobin Change Over 24 Weeks

    Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline.

    After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated.

    4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion.

    Measured: Week 1 through Week 24

  3. Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG

    The percentage of participants meeting the modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.

    Measured: Week 1 through Week 24

  4. Time to Hematologic Improvement - Erythroid Response (HI-E)

    Time from first dose to first onset of achieving modified HI-E.

    The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.

    Measured: Week 1 through Week 24

  5. Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 12 Weeks (84 Days)

    Percentage of participants who are RBC transfusion-free over a consecutive 84-day period.

    Measured: Week 1 through Week 24

  6. Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)

    Maximum duration of RBC transfusion independence for participants who achieve RBC-TI ≥ 84 days.

    Measured: Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)

  7. Time to Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)

    Time from first dose to first onset of transfusion independence ≥ 84 days.

    Measured: Week 1 through Week 24

  8. Time to First Red Blood Cell (RBC) Transfusion

    Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method.

    Measured: Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)

  9. The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment

    RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1.

    Measured: Week 1 through Week 24

  10. Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 56 Days (8 Weeks)

    Defined as percentage of participants achieving RBC-TI for >= 56 days during any consecutive 56-day period from Week 1 through Week 24.

    Measured: Week 1 through Week 24

  11. Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period

    Defined as percentage of participants achieving RBC-TI for >= 168 days during any consecutive 168-day period from Week 1 through Week 48.

    Measured: Week 1 through Week 48

  12. The Number of Participants With Acute Myeloid Leukemia (AML) Progression

    Progression to AML is defined as a diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow.

    Measured: From randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)

  13. Median Time to Acute Myeloid Leukemia (AML) Progression

    Time to AML progression is defined as the time between randomization and first diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow. Participants with diagnosis of AML will be considered to have had an event. Participants who have not progressed to AML at the time of analysis will be censored at the last assessment date which does not indicate progression to AML estimated by Kaplan-Meier method.

    Measured: From randomization to first diagnosis of AML up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)

  14. Overall Survival (OS)

    Time from date of randomization to death due to any cause

    Measured: Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)

  15. The Number of Participants With Adverse Events (AEs)

    Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment.

    The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.

    Measured: From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)

  16. Number of Participants With a Positive Anti-drug Antibody (ADA) Test

    Number of participants under each ADA positive category. A participant is counted as 'Treatment-Emergent' if there is a positive post-baseline sample while the baseline sample is ADA negative, or there is a positive post-baseline sample with a titer >= 4-fold of the baseline titer while the baseline sample is ADA positive. A participant is counted as 'Preexisting' if the baseline sample is ADA positive and the participant is not qualified for 'Treatment-Emergent'. If the participant was discontinued from study treatment earlier than one year from the first dose, additional samples will be collected if last ADA is positive.

    Baseline is defined as the last value on or before the first dose of study drug.

    Measured: Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose

  17. Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)

    The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug.

    Measured: Baseline and week 24.

  18. Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)

    The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:

    • Physical well-being (sum of 7 items, score range from 0-28)
    • Social/Family well-being (sum of 7 items, score range from 0-28)
    • Emotional well-being (sum of 6 items, score range from 0-24)
    • Functional well-being (sum of 7 items, score range from 0-28)
    • Anemia-related symptoms (sum of 20 items, score range from 0-80)

    A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug.

    Measured: Baseline, Day 1 on weeks 7,13,19, and 24.

  19. Area Under the Concentration-time Curve [AUC]

    Measured: Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose

  20. Maximum Plasma Concentration of Drug [Cmax]

    Measured: Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start2 Jan 2019
  3. Primary completion31 Mar 2023
  4. Study completion28 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03682536
Sponsor's protocol ID
ACE-536-MDS-002
Other IDs
U1111-1218-1810, 2022-501485-22
Acronym
COMMANDS
Status last verified
Oct 2024
First submitted
7 Sep 2018
Last updated
20 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Komrokji RS, Hayati S, Ugidos M, Garcia-Manero G, Della Porta MG, Zeidan AM, Santini V, Platzbecker U, Gandhi AK, Suragani RNVS. Impact of Mutational Landscape and Burden on RBC Transfusion Response in Patients With Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the COMMANDS Study. Am J Hematol. 2026 Mar;101(3):427-438. doi: 10.1002/ajh.70171. Epub 2026 Jan 19.

    PubMed 41549790

  • 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.

    PubMed 40377899

  • 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.

    PubMed 39038479

  • 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.

    PubMed 37311468

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Luspatercept and Epoetin alfa in people with Myelodysplastic Syndromes, run by Celgene at 226 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Japan, France, Australia, Germany and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL (time frame: Week 1 through Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03682536, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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