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A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants (MAXILUS)

Primary Purpose

Myelodysplastic Syndromes

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Luspatercept
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Luspatercept, Transfusion dependent, ACE-536, Anemia, Blood Transfusion, Red Blood Cell Transfusion, Myelodysplastic Syndrome

Eligibility Criteria

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

Inclusion Criteria: Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. Participant has had a prior allogeneic or autologous stem cell transplant. Participant has known history or diagnosis of AML. Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Cancer and Blood Specialty ClinicRecruiting
  • Scripps Prebys Cancer Center
  • Smilow Cancer Hospital at Yale New Haven
  • Sylvester Comprehensive Cancer Center-Miami
  • University of Kansas Medical Center
  • Mercy Health - Paducah Medical Oncology and Hematology
  • UMass Memorial Medical Center
  • Henry Ford Hospital
  • Dartmouth Hitchcock Medical Center
  • Icahn School of Medicine at Mount Sinai
  • James Cancer Hospital and Solove Research Institute - 460 W 10th Ave
  • Oncology Associates of Oregon, P.C.
  • West Penn Hospital
  • Texas Oncology - Amarillo
  • North Houston Cancer Clinics - HuntsvilleRecruiting
  • Wheeling Hospital Schiffler Cancer Center
  • Froedtert and The Medical College of Wisconsin
  • Local Institution - 0016
  • Local Institution - 0008
  • Local Institution - 0004
  • Local Institution - 0023
  • Local Institution - 0041
  • Local Institution - 0044
  • Local Institution - 0026
  • Local Institution - 0007
  • Local Institution - 0046
  • Local Institution - 0053
  • Local Institution - 0001
  • Local Institution - 0013
  • Local Institution - 0040
  • Local Institution - 0037
  • Local Institution - 0009
  • Local Institution - 0021
  • Local Institution - 0050
  • Local Institution - 0014
  • Local Institution - 0045
  • Local Institution - 0024
  • Local Institution - 0015
  • Local Institution - 0029
  • Local Institution - 0002
  • Local Institution - 0030
  • Local Institution - 0049
  • Local Institution - 0010
  • Local Institution - 0034
  • Local Institution - 0035
  • Auxilio Mutuo Cancer Center
  • Local Institution - 0017
  • Local Institution - 0005
  • Local Institution - 0052
  • Local Institution - 0039
  • Local Institution - 0038
  • Local Institution - 0027
  • Local Institution - 0028
  • Local Institution - 0018

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

Cohort 2: ESA relapsed or refractory

Arm Description

Outcomes

Primary Outcome Measures

Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24

Secondary Outcome Measures

Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT
Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT
Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT
Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT
Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Number of participants with adverse events (AEs)
Number of participants with acute myeloid leukemia (AML) progression
Time to AML progression
Time from treatment start date to death due to any cause
Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT

Full Information

First Posted
September 13, 2023
Last Updated
October 4, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT06045689
Brief Title
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Acronym
MAXILUS
Official Title
A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
December 30, 2027 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Luspatercept, Transfusion dependent, ACE-536, Anemia, Blood Transfusion, Red Blood Cell Transfusion, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Arm Type
Experimental
Arm Title
Cohort 2: ESA relapsed or refractory
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Luspatercept
Other Intervention Name(s)
BMS-986346, ACE-536, REBLOZYL
Intervention Description
Specified dose on specified days.
Primary Outcome Measure Information:
Title
Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24
Time Frame
Up to week 24
Secondary Outcome Measure Information:
Title
Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Time Frame
Up to week 48
Title
Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT
Time Frame
Up to 2 years
Title
Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT
Time Frame
Up to 2 years
Title
Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame
Up to 2 years
Title
Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Time Frame
Up to week 48
Title
Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Time Frame
Up to week 48
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 2 years
Title
Number of participants with acute myeloid leukemia (AML) progression
Time Frame
Up to 4 years
Title
Time to AML progression
Time Frame
Up to 4 years
Title
Time from treatment start date to death due to any cause
Time Frame
Up to 4 years
Title
Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. Participant has had a prior allogeneic or autologous stem cell transplant. Participant has known history or diagnosis of AML. Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect www.BMSStudyconnect.com
Phone
855-907-3286
Email
Clincal.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
Cancer and Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3379
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vu Phan, Site 0051
Phone
562-735-0602
Facility Name
Scripps Prebys Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-2106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marin Xavier, Site 0048
Phone
619-713-7900
Facility Name
Smilow Cancer Hospital at Yale New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Zeidan, Site 0033
Phone
203-737-7078
Facility Name
Sylvester Comprehensive Cancer Center-Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeetha Venugopal, Site 0042
Phone
888-888-8888
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-8500
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Gonzalez Lugo, Site 0020
Phone
913-945-6674
Facility Name
Mercy Health - Paducah Medical Oncology and Hematology
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003-7915
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wederson Claudino, Site 0025
Phone
000-000-0000
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Gerber, Site 0012
Phone
508-635-7093
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Mattour, Site 0011
Phone
313-433-1718
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christi Hayes, Site 0019
Phone
603-650-4628
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lewis Silverman, Site 0032
Phone
212-241-5520
Facility Name
James Cancer Hospital and Solove Research Institute - 460 W 10th Ave
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uma Borate, Site 0006
Phone
503-418-2294
Facility Name
Oncology Associates of Oregon, P.C.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-6043
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Fletcher, Site 0054
Phone
541-683-5001
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Koget, Site 0036
Facility Name
Texas Oncology - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106-1781
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Praveen Kumar Tumula, Site 0043
Phone
806-358-8654
Facility Name
North Houston Cancer Clinics - Huntsville
City
Huntsville
State/Province
Texas
ZIP/Postal Code
77340
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elham Abbasi-Hafshejani, Site 0022
Phone
936-439-5213
Facility Name
Wheeling Hospital Schiffler Cancer Center
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003-6379
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavana Bhatnagar, Site 0031
Phone
614-293-7961
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Narra, Site 0003
Phone
414-805-4600
Facility Name
Local Institution - 0016
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0008
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0004
City
Praha 2
State/Province
Praha, Hlavní Mesto
ZIP/Postal Code
128 21
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0023
City
Praha
State/Province
Praha, Hlavní Mesto
ZIP/Postal Code
128 20
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0041
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
Site 0041
Facility Name
Local Institution - 0044
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0026
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0007
City
Grenoble cedex 09
ZIP/Postal Code
38 38043
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0046
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0046
Facility Name
Local Institution - 0053
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0001
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0013
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0040
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30161
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0037
City
Gütersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0009
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 0009
Facility Name
Local Institution - 0021
City
Reggio Calabria
State/Province
Calabria
ZIP/Postal Code
89124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0050
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0014
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0045
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0024
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0015
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0029
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0002
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0030
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0049
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0010
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0034
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0035
City
Wałbrzych
ZIP/Postal Code
58-309
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Auxilio Mutuo Cancer Center
City
San Juan
ZIP/Postal Code
00917-5032
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelba Torres Lopez, Site 0047
Phone
7877582000
Facility Name
Local Institution - 0017
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0005
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0052
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0039
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0038
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0027
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0028
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0018
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

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