Back to resultsELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (ELEMENT-MDS)
Primary Purpose
Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Luspatercept
Epoetin Alfa
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Luspatercept, BMS-986346, ACE-536, Myelodysplastic Syndrome, Epoetin alfa, Erythropoietin stimulating agent (ESA), Myelodysplastic Syndromes (MDS), Anaemia
Eligibility Criteria
Inclusion Criteria: Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and: i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood. Participant is not transfusion dependent (NTD) based on IWG2018 criteria Participant has never received treatment with an erythropoiesis stimulating agent (ESA) Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L. Participant has symptoms of anemia: i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period. Participant has a mean baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. Mean Hb is defined as the mean of all central/ local/ pretransfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart). Only Hb levels > 21 days following a transfusion are acceptable. The last measurement must be within 35 days of randomization. Exclusion Criteria: Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases). Participant with known history of diagnosis of AML. Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization. Participant with a history of pure red cell aplasia and/or antibody against erythropoietin. Note: Other protocol-defined inclusion/exclusion criteria apply.
Sites / Locations
- John Muir Medical Center - Concord Campus
- Compassionate Cancer Care Medical Group
- Ventura County Hematology Oncology Specialists
- Innovative Clinical Research Institute
- Florida Cancer Specialists - South
- Baptist MD Anderson Cancer Center
- D&H Cancer Research Center LLC
- Florida Cancer Specialists - North
- Hematology/Oncology of the North Shore
- Orchard Healthcare Research Inc.Recruiting
- American Oncology Partners of Maryland, PARecruiting
- Metro-Minnesota Community Clinical Oncology
- Hattiesburg Clinic Hematology/OncologyRecruiting
- University of New Mexico Comprehensive Cancer Center
- Cleveland Clinic
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
- Avera Cancer Institute
- University of Tennessee Medical CenterRecruiting
- Mays Cancer Center
- Kadlec Clinic Hematology and Oncology
- Fred Hutchinson Cancer Center at University of Washington Medical Center - Northwest
- Local Institution - 0010Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0009
- Local Institution - 0071
- Local Institution - 0113
- Local Institution - 0054
- Local Institution - 0052
- Local Institution - 0059
- Local Institution - 0101
- Local Institution - 0056
- Local Institution - 0003
- Local Institution - 0049
- Local Institution - 0050
- Local Institution - 0017
- Local Institution - 0109
- Local Institution - 0217
- Local Institution - 0030
- Local Institution - 0223
- Local Institution - 0096
- Local Institution - 0220
- Local Institution - 0031
- Local Institution - 0221Recruiting
- Local Institution - 0038
- Local Institution - 0194
- Local Institution - 0108
- Local Institution - 0089
- Local Institution - 0032
- Local Institution - 0079
- Local Institution - 0043
- Local Institution - 0048
- Local Institution - 0216
- Local Institution - 0111
- Local Institution - 0218
- Local Institution - 0075
- Local Institution - 0103
- Local Institution - 0029
- Local Institution - 0033
- Local Institution - 0147
- Local Institution - 0152
- Local Institution - 0149
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
- CHU Bordeaux Haut-Leveque
- Chu Grenoble Alpes
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
- Hôpital Saint-Louis
- Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
- Local Institution - 0168
- Local Institution - 0171
- Local Institution - 0169
- Local Institution - 0028
- Local Institution - 0207
- Local Institution - 0167
- Local Institution - 0166
- Local Institution - 0132
- Local Institution - 0084
- Local Institution - 0131
- Local Institution - 0082
- Local Institution - 0024
- Local Institution - 0021
- Local Institution - 0026
- Local Institution - 0193
- Local Institution - 0178
- Local Institution - 0185
- Local Institution - 0137
- Local Institution - 0134
- Local Institution - 0136
- Local Institution - 0138
- Local Institution - 0135
- Local Institution - 0076
- Local Institution - 0085
- Local Institution - 0133
- Local Institution - 0142
- Local Institution - 0069
- Local Institution - 0150
- Local Institution - 0130
- Local Institution - 0062
- Local Institution - 0060
- Local Institution - 0061
- Auxilio Mutuo Cancer Center
- Local Institution - 0198
- Local Institution - 0197
- Local Institution - 0196
- Local Institution - 0199
- Local Institution - 0200
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Luspatercept
Epoetin Alfa
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018.
Secondary Outcome Measures
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Mean Hb change over fixed 24-week periods compared to the baseline Hb
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week treatment period in the absence of transfusion
Number of participants with TD by week 48
Time to TD (IWG 2018 defined as ≥ 3 RBC units/16 weeks) during any continuous 16-week interval until the end of study
Time from first Luspatercept dose to first RBC transfusion
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 48-week treatment period in absence of transfusion
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 96-week treatment period in absence of transfusion
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion)
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week Treatment Period in the absence of transfusion)
Number of participants with RBC transfusion independence over at least a consecutive 24-week period
Number of transfusions
Number of transfusions visits/units
Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An)
Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L)
Number of participants with adverse events (AEs)
Number of participants with antidrug antibody (ADA) (positive or negative)
Pharmacokinetics (PK): Serum concentration
PK: Area under the plasma concentration time curve (AUC)
Number of participants with a platelet response at Week 24, Week 48 and Week 96
Platelet response is defined as an increase from baseline in number of platelets to ≥ 30 × 10^9/L at Week 24, Week 48 and Week 96.
Number of participants with a neutrophil response at Week 24, Week 48 and Week 96
Neutrophil response is defined as an absolute increase from baseline of > 0.5 × 10^9/L neutrophils at Week 24, Week 48 and Week 96.
Number of participants with acute myeloid leukemia (AML) progression
Time to AML progression
Number of participants with high risk myelodysplastic syndromes (MDS) progression
Time to high-risk MDS progression
Time from date of randomization up to death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05949684
Brief Title
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
Acronym
ELEMENT-MDS
Official Title
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
June 25, 2027 (Anticipated)
Study Completion Date
March 11, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
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 the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Luspatercept, BMS-986346, ACE-536, Myelodysplastic Syndrome, Epoetin alfa, Erythropoietin stimulating agent (ESA), Myelodysplastic Syndromes (MDS), Anaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Luspatercept
Arm Type
Experimental
Arm Title
Epoetin Alfa
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Luspatercept
Other Intervention Name(s)
BMS-986346, ACE-536, Reblozyl®
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Epoetin Alfa
Other Intervention Name(s)
Epogen®, PROCRIT®, BINOCRIT
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
Description
TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018.
Time Frame
Up to Week 96
Secondary Outcome Measure Information:
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion
Time Frame
Up to Week 48
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
Up to Week 48
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
From Week 49 to Week 96
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
Up to Week 96
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
Up to Week 48
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
From Week 49 to Week 96
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame
Up to Week 96
Title
Mean Hb change over fixed 24-week periods compared to the baseline Hb
Time Frame
Baseline, Week 24, Week 48, Week 72, Week 96
Title
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week treatment period in the absence of transfusion
Time Frame
Up to Week 96
Title
Number of participants with TD by week 48
Time Frame
Up to Week 48
Title
Time to TD (IWG 2018 defined as ≥ 3 RBC units/16 weeks) during any continuous 16-week interval until the end of study
Time Frame
Up to 5 years
Title
Time from first Luspatercept dose to first RBC transfusion
Time Frame
Up to 5 years
Title
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 48-week treatment period in absence of transfusion
Time Frame
Up to Week 48
Title
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 96-week treatment period in absence of transfusion
Time Frame
Up to Week 96
Title
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion)
Time Frame
Up to Week 48
Title
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week Treatment Period in the absence of transfusion)
Time Frame
Up to Week 96
Title
Number of participants with RBC transfusion independence over at least a consecutive 24-week period
Time Frame
Up to 5 years
Title
Number of transfusions
Time Frame
Up to 5 years
Title
Number of transfusions visits/units
Time Frame
Up to 5 years
Title
Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An)
Time Frame
Baseline, Up to 5 years
Title
Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L)
Time Frame
Baseline, Up to 5 years
Title
Number of participants with adverse events (AEs)
Time Frame
Up to Week 102
Title
Number of participants with antidrug antibody (ADA) (positive or negative)
Time Frame
Up to Week 102
Title
Pharmacokinetics (PK): Serum concentration
Time Frame
Up to Week 96
Title
PK: Area under the plasma concentration time curve (AUC)
Time Frame
Up to Week 96
Title
Number of participants with a platelet response at Week 24, Week 48 and Week 96
Description
Platelet response is defined as an increase from baseline in number of platelets to ≥ 30 × 10^9/L at Week 24, Week 48 and Week 96.
Time Frame
Up to Week 96
Title
Number of participants with a neutrophil response at Week 24, Week 48 and Week 96
Description
Neutrophil response is defined as an absolute increase from baseline of > 0.5 × 10^9/L neutrophils at Week 24, Week 48 and Week 96.
Time Frame
Up to Week 96
Title
Number of participants with acute myeloid leukemia (AML) progression
Time Frame
Up to 5 years
Title
Time to AML progression
Time Frame
Up to 5 years
Title
Number of participants with high risk myelodysplastic syndromes (MDS) progression
Time Frame
Up to 5 years
Title
Time to high-risk MDS progression
Time Frame
Up to 5 years
Title
Time from date of randomization up to death due to any cause
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and: i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
Participant is not transfusion dependent (NTD) based on IWG2018 criteria
Participant has never received treatment with an erythropoiesis stimulating agent (ESA)
Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
Participant has symptoms of anemia: i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
Participant has a mean baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. Mean Hb is defined as the mean of all central/ local/ pretransfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart). Only Hb levels > 21 days following a transfusion are acceptable. The last measurement must be within 35 days of randomization.
Exclusion Criteria:
Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
Participant with known history of diagnosis of AML.
Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
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
John Muir Medical Center - Concord Campus
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gigi Chen, Site 0183
Phone
925-674-2580
Facility Name
Compassionate Cancer Care Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haresh Jhangiani, Site 0179
Phone
951-371-2411
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Kong, Site 0209
Phone
000-000-0000
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Zafar, Site 0202
Phone
239-274-9930
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Norkin, Site 0180
Phone
248-756-4524
Facility Name
D&H Cancer Research Center LLC
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kahn, Site 0224
Phone
954-773-9890
Facility Name
Florida Cancer Specialists - North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Fonseca, Site 0201
Phone
000-000-0000
Facility Name
Hematology/Oncology of the North Shore
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlon Kleinman, Site 0170
Phone
000-000-0000
Facility Name
Orchard Healthcare Research Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Oliff, Site 0184
Phone
224-534-7580
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Boccia, Site 0007
Phone
301-571-2016
Facility Name
Metro-Minnesota Community Clinical Oncology
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ji, Site 0222
Phone
952-993-3252
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hrom, Site 0128
Phone
601-261-1700
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uma Borate, Site 0206
Phone
503-418-2294
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wahid Hanna, Site 0174
Phone
865-544-9171
Facility Name
Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rangaswamy Chintapatla, Site 0203
Phone
509-783-4637
Facility Name
Fred Hutchinson Cancer Center at University of Washington Medical Center - Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Martin, Site 0213
Phone
206-606-5800
Facility Name
Local Institution - 0010
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0012
City
Buenos Aires
ZIP/Postal Code
CP1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0009
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0071
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0071
Facility Name
Local Institution - 0113
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0113
Facility Name
Local Institution - 0054
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0052
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0059
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-270
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0101
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0101
Facility Name
Local Institution - 0056
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0003
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0049
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0050
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0017
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0109
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0109
Facility Name
Local Institution - 0217
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0217
Facility Name
Local Institution - 0030
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0223
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0223
Facility Name
Local Institution - 0096
City
Fuzhou Fujian
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0220
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0220
Facility Name
Local Institution - 0031
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
450008
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0221
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0221
Facility Name
Local Institution - 0038
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0194
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0194
Facility Name
Local Institution - 0108
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430058
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0108
Facility Name
Local Institution - 0089
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0089
Facility Name
Local Institution - 0032
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0079
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0043
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0048
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0216
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0216
Facility Name
Local Institution - 0111
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0111
Facility Name
Local Institution - 0218
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0218
Facility Name
Local Institution - 0075
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0075
Facility Name
Local Institution - 0103
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0103
Facility Name
Local Institution - 0029
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0033
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0147
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
05034
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0147
Facility Name
Local Institution - 0152
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0152
Facility Name
Local Institution - 0149
City
Montería
State/Province
Córdoba
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0149
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau, Site 0011
Phone
33492039268
Facility Name
CHU Bordeaux Haut-Leveque
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dimicoli-Salazar, Site 0016
Phone
33557656511
Facility Name
Chu Grenoble Alpes
City
La Tronche
State/Province
Isère
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Meunier, Site 0116
Phone
33476765755
Facility Name
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
City
Vandoeuvre lès Nancy
State/Province
Lorraine
ZIP/Postal Code
54511
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud D'Aveni, Site 0165
Phone
0609481716
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FENAUX, Site 0015
Phone
+33171207022
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault Comont, Site 0140
Phone
0033531156266
Facility Name
Local Institution - 0168
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0168
Facility Name
Local Institution - 0171
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0171
Facility Name
Local Institution - 0169
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0169
Facility Name
Local Institution - 0028
City
Berlin
ZIP/Postal Code
14195
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0207
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0207
Facility Name
Local Institution - 0167
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0167
Facility Name
Local Institution - 0166
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0166
Facility Name
Local Institution - 0132
City
Patras
State/Province
Achaḯa
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0132
Facility Name
Local Institution - 0084
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0084
Facility Name
Local Institution - 0131
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0131
Facility Name
Local Institution - 0082
City
Alexandroupolis
ZIP/Postal Code
08100
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0082
Facility Name
Local Institution - 0024
City
Eger
State/Province
Heves
ZIP/Postal Code
0
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0021
City
Nyiregyhaza
State/Province
Szabolcs-Szatmár-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0026
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0193
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0193
Facility Name
Local Institution - 0178
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751003
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0178
Facility Name
Local Institution - 0185
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0185
Facility Name
Local Institution - 0137
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0137
Facility Name
Local Institution - 0134
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0134
Facility Name
Local Institution - 0136
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0136
Facility Name
Local Institution - 0138
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0138
Facility Name
Local Institution - 0135
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0135
Facility Name
Local Institution - 0076
City
Reggio Calabria
ZIP/Postal Code
89125
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0076
Facility Name
Local Institution - 0085
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0085
Facility Name
Local Institution - 0133
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0133
Facility Name
Local Institution - 0142
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0142
Facility Name
Local Institution - 0069
City
Huixquilucan
ZIP/Postal Code
52787
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0150
City
Puebla
ZIP/Postal Code
72424
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0150
Facility Name
Local Institution - 0130
City
Wałbrzych
State/Province
Dolnośląskie
ZIP/Postal Code
58-309
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0130
Facility Name
Local Institution - 0062
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-106
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0062
Facility Name
Local Institution - 0060
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0061
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Auxilio Mutuo Cancer Center
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelba Torres Lopez, Site 0219
Phone
7877582000
Facility Name
Local Institution - 0198
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0198
Facility Name
Local Institution - 0197
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0197
Facility Name
Local Institution - 0196
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0196
Facility Name
Local Institution - 0199
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0199
Facility Name
Local Institution - 0200
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0200
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
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