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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 (COMMANDS)

Primary Purpose

Myelodysplastic Syndromes

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Luspatercept
Epoetin alfa
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Luspatercept, ACE-536, Anemia, Myelodysplastic Syndromes, Blood Transfusion, RBC Transfusion, Erythropoiesis-stimulating agents, Erythropoietin, Myelodysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Local Institution - 107
  • Local Institution - 115
  • Local Institution - 101
  • Local Institution - 104
  • Local Institution - 136
  • Local Institution - 119
  • Local Institution - 120
  • Local Institution - 122
  • Local Institution - 108
  • Local Institution - 118
  • Local Institution - 102
  • Local Institution - 123
  • Local Institution - 117
  • Local Institution - 134
  • Local Institution - 113
  • Local Institution - 105
  • Local Institution - 131
  • Univ of Pittsburgh Medical Center
  • Local Institution - 111
  • Tennessee Oncology
  • Baylor University Medical Center
  • Local Institution - 109
  • Utah Cancer Specialists - South Salt Lake
  • Local Institution - 132
  • Local Institution - 127
  • Local Institution - 206
  • Local Institution - 213
  • Local Institution - 200
  • Local Institution - 215
  • Local Institution - 211
  • Local Institution - 210
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  • Local Institution - 471
  • Local Institution - 474
  • Local Institution - 472
  • Local Institution - 473
  • Local Institution - 470
  • Local Institution - 476
  • Local Institution - 147
  • Local Institution - 145
  • Local Institution - 142
  • Local Institution - 140
  • Local Institution - 141
  • Local Institution - 144
  • Local Institution - 148
  • Local Institution - 151
  • Local Institution - 152
  • Local Institution - 560
  • Local Institution - 564
  • Local Institution - 563
  • Local Institution - 562
  • Local Institution - 561
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  • Local Institution - 312
  • Local Institution - 311
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  • Local Institution - 305
  • Local Institution - 309
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  • Local Institution - 400

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Luspatercept

Epoetin alfa

Arm Description

Outcomes

Primary Outcome Measures

Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL

Secondary Outcome Measures

RBC-TI for 24 weeks
Mean hemoglobin change over 24 weeks
Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG)
Time to HI-E
RBC-TI for ≥ 12 weeks (84 days)
Duration of RBC-TI ≥ 12 weeks (84 days)
Time to RBC-TI ≥ 12 weeks (84 days)
Time to first red blood cell (RBC) transfusion
RBC transfusion burden on treatment
RBC-TI for ≥ 56 days (8 weeks)
RBC-TI for a consecutive 24-week period
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30)
The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire
Number of participants with Adverse Events (AEs)
Pharmacokinetic - area under the concentration-time curve (AUC)
Pharmacokinetic - maximum plasma concentration of drug (Cmax)
Frequency of antidrug antibodies (ADA)
Number of participants progressing to acute myeloid leukemia (AML)
Percentage of participants progressing to AML
Time to AML progression
Overall survival

Full Information

First Posted
September 7, 2018
Last Updated
October 13, 2023
Sponsor
Celgene
Collaborators
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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1. Study Identification

Unique Protocol Identification Number
NCT03682536
Brief Title
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
Acronym
COMMANDS
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) ESA in Native Subjects Who Require Red Blood Cell Transfusions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
September 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Luspatercept, ACE-536, Anemia, Myelodysplastic Syndromes, Blood Transfusion, RBC Transfusion, Erythropoiesis-stimulating agents, Erythropoietin, Myelodysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Luspatercept
Arm Type
Experimental
Arm Title
Epoetin alfa
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Luspatercept
Other Intervention Name(s)
ACE-536
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Other Intervention Name(s)
EPREX®, ERYPO®, PROCRIT®
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
RBC-TI for 24 weeks
Time Frame
Week 1 through Week 24
Title
Mean hemoglobin change over 24 weeks
Time Frame
Week 1 through Week 24
Title
Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG)
Time Frame
Week 1 through Week 24
Title
Time to HI-E
Time Frame
Week 1 through Week 24
Title
RBC-TI for ≥ 12 weeks (84 days)
Time Frame
Week 1 through Week 24
Title
Duration of RBC-TI ≥ 12 weeks (84 days)
Time Frame
Week 1 through End of Treatment (EOT), up to approximately 60 months
Title
Time to RBC-TI ≥ 12 weeks (84 days)
Time Frame
Week 1 through Week 24
Title
Time to first red blood cell (RBC) transfusion
Time Frame
Week 1 through EOT, up to approximately 60 months
Title
RBC transfusion burden on treatment
Time Frame
Week 1 through Week 24
Title
RBC-TI for ≥ 56 days (8 weeks)
Time Frame
Week 1 through Week 24
Title
RBC-TI for a consecutive 24-week period
Time Frame
Week 1 through Week 48
Title
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30)
Time Frame
Screening through Week 24
Title
The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire
Time Frame
Screening through Week 24
Title
Number of participants with Adverse Events (AEs)
Time Frame
Week 1 through 42 days post last dose
Title
Pharmacokinetic - area under the concentration-time curve (AUC)
Time Frame
Randomization through 1-year post first dose
Title
Pharmacokinetic - maximum plasma concentration of drug (Cmax)
Time Frame
Randomization through 1-year post first dose
Title
Frequency of antidrug antibodies (ADA)
Time Frame
Randomization through 1-year post first dose
Title
Number of participants progressing to acute myeloid leukemia (AML)
Time Frame
Randomization through up to 60 months
Title
Percentage of participants progressing to AML
Time Frame
Randomization through up to 60 months
Title
Time to AML progression
Time Frame
Randomization through up to 60 months
Title
Overall survival
Time Frame
Randomization through up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 107
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Local Institution - 115
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution - 101
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Local Institution - 104
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 136
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Local Institution - 119
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Local Institution - 120
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution - 122
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Local Institution - 108
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 118
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Local Institution - 102
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Local Institution - 123
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Local Institution - 117
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Local Institution - 134
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Local Institution - 113
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 105
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Local Institution - 131
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Univ of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 111
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1625
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 109
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists - South Salt Lake
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Local Institution - 132
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Local Institution - 127
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Local Institution - 206
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Local Institution - 213
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Local Institution - 200
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution - 215
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution - 211
City
Nowra
State/Province
New South Wales
ZIP/Postal Code
2541
Country
Australia
Facility Name
Local Institution - 210
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Local Institution - 207
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Local Institution - 208
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Local Institution - 202
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 204
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 203
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Local Institution - 209
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution - 205
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Local Institution - 212
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Local Institution - 442
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Local Institution - 441
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 475
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Local Institution - 471
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Local Institution - 474
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 472
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Local Institution - 473
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Local Institution - 470
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 476
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Local Institution - 147
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution - 145
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution - 142
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution - 140
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution - 141
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Local Institution - 144
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 148
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 151
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Local Institution - 152
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution - 560
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 564
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Local Institution - 563
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 562
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 561
City
Praha
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
Local Institution - 317
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Local Institution - 312
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Local Institution - 311
City
Caen Cedex 9
ZIP/Postal Code
14033
Country
France
Facility Name
Local Institution - 306
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution - 305
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Local Institution - 309
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 303
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Local Institution - 307
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 301
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution - 302
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution - 313
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution - 308
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 315
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 316
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 314
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Local Institution - 300
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 310
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution - 304
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution - 422
City
Baden-Warttemberg
ZIP/Postal Code
73557
Country
Germany
Facility Name
Local Institution - 424
City
Berlin
ZIP/Postal Code
14195
Country
Germany
Facility Name
Local Institution - 426
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 429
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
Facility Name
Local Institution - 420
City
Dusseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Local Institution - 431
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Local Institution - 435
City
Keil
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 423
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Local Institution - 428
City
Köln
ZIP/Postal Code
50677
Country
Germany
Facility Name
Local Institution - 430
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 436
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution - 421
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 425
City
Winnenden
ZIP/Postal Code
71364
Country
Germany
Facility Name
Local Institution - 427
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Local Institution - 389
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
71110
Country
Greece
Facility Name
Local Institution - 396
City
Alexandroupolis
ZIP/Postal Code
08100
Country
Greece
Facility Name
Local Institution - 397
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Local Institution - 391
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Local Institution - 392
City
Athens
ZIP/Postal Code
12464
Country
Greece
Facility Name
Local Institution - 395
City
Athina
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Local Institution - 398
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Local Institution - 393
City
Rio Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Local Institution - 399
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Local Institution - 390
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Local Institution - 535
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Local Institution - 534
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution - 536
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Local Institution - 386
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Local Institution - 383
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution - 384
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 381
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Local Institution - 385
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Local Institution - 382
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 380
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution - 331
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution - 324
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 327
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution - 330
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 321
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Local Institution - 329
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 326
City
Reggio Di Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Local Institution - 328
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Local Institution - 332
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Local Institution - 325
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 323
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 322
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Local Institution - 238
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Local Institution - 244
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Local Institution - 236
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 247
City
Amagasaki-Shi
ZIP/Postal Code
660-0892
Country
Japan
Facility Name
Local Institution - 249
City
Fujisawa-Shi
ZIP/Postal Code
251-0052
Country
Japan
Facility Name
Local Institution - 234
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Local Institution - 237
City
Hitachi, Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Local Institution - 231
City
Kamogawa
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution - 248
City
Kitakyushu-Shi
ZIP/Postal Code
806-0034
Country
Japan
Facility Name
Local Institution - 270
City
Nagaoka-Shi
ZIP/Postal Code
940-2108
Country
Japan
Facility Name
Local Institution - 243
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Local Institution - 241
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Local Institution - 235
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Local Institution - 242
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 233
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Local Institution - 246
City
Sapporo-shi
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Local Institution - 239
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Local Institution - 232
City
Shibuya-ku
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Local Institution - 245
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Local Institution - 230
City
Shinagawa-ku, Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Local Institution - 251
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Local Institution - 257
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution - 250
City
Hwasun-Gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution - 253
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution - 252
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 256
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Local Institution - 255
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Local Institution - 254
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Local Institution - 540
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Local Institution - 541
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Local Institution - 462
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution - 461
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Local Institution - 464
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Local Institution - 460
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Local Institution - 463
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Local Institution - 570
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Local Institution - 575
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 572
City
Lubin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution - 576
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Local Institution - 573
City
Rzwszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Local Institution - 579
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Local Institution - 578
City
Walbrzych
ZIP/Postal Code
58-309
Country
Poland
Facility Name
Local Institution - 577
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Local Institution - 571
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Local Institution - 373
City
Beja
ZIP/Postal Code
7801-849
Country
Portugal
Facility Name
Local Institution - 371
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Local Institution - 372
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Local Institution - 370
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution - 374
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Local Institution - 511
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Local Institution - 505
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Local Institution - 509
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Local Institution - 504
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Local Institution - 507
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Local Institution - 500
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Local Institution - 503
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Local Institution - 508
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Local Institution - 506
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Local Institution - 510
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution - 502
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Local Institution - 358
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 350
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 354
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Local Institution - 352
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 355
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 353
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 361
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Local Institution - 356
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Local Institution - 363
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Local Institution - 362
City
Palma de Mallorca
ZIP/Postal Code
7120
Country
Spain
Facility Name
Local Institution - 351
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution - 360
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 357
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution - 359
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 550
City
Goteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Local Institution - 552
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Local Institution - 551
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Local Institution - 450
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 452
City
Luzern 16
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Local Institution - 451
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
Local Institution - 220
City
Changhua City, Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Local Institution - 222
City
Niaosong District Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution - 223
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution - 224
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution - 221
City
Taipei, Zhongzheng Dist.
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 342
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution - 340
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Facility Name
Local Institution - 343
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Local Institution - 526
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Local Institution - 525
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Local Institution - 522
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Facility Name
Local Institution - 520
City
Lvov
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Local Institution - 523
City
Mykolaiv
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
Local Institution - 521
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Local Institution - 401
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Local Institution - 403
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Local Institution - 405
City
Headington, Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Local Institution - 407
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Local Institution - 404
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution - 400
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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