A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

April 8, 2024 updated by: Bristol-Myers Squibb

A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP1280AEB
        • Recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • Centro Mdico "Barrio Parque"
        • Contact:
          • Claudio Iastrebner, Site 0016
          • Phone Number: +54-911-69816300
      • Buenos Aires, Argentina, 1431
        • Active, not recruiting
        • Local Institution - 0022
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1118AAT
        • Withdrawn
        • Local Institution - 0021
  • Australia
      • Melbourne, Australia, 3004
        • Active, not recruiting
        • Local Institution - 0003
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Withdrawn
        • Local Institution - 0144
      • Macquarie University, New South Wales, Australia, 2109
        • Withdrawn
        • Local Institution - 0145
      • Wollongong, New South Wales, Australia, 2500
        • Withdrawn
        • Local Institution - 0146
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Active, not recruiting
        • Local Institution - 0006
      • Heidelberg, Victoria, Australia, 3084
        • Withdrawn
        • Local Institution - 0069
      • Melbourne, Victoria, Australia, 3000
        • Completed
        • Local Institution - 0018
      • Melbourne, Victoria, Australia, 3065
        • Completed
        • Local Institution - 0004
  • Austria
      • Salzburg, Austria, 5020
        • Withdrawn
        • Local Institution - 0074
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Withdrawn
        • Local Institution - 0034
    • Wien
      • Vienna, Wien, Austria, 1140
        • Withdrawn
        • Local Institution - 0029
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Withdrawn
        • Local Institution - 0091
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Active, not recruiting
        • Local Institution - 0008
      • Toronto, Ontario, Canada, M5G 2M9
        • Active, not recruiting
        • Local Institution - 0015
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Completed
        • Local Institution - 0090
  • China
      • Zhengzhou, China, 450008
        • Withdrawn
        • Local Institution - 0170
    • Beijing
      • Beijing, Beijing, China, 100034
        • Not yet recruiting
        • Local Institution - 0171
        • Contact:
          • Site 0171
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Withdrawn
        • Local Institution - 0167
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Local Institution - 0156
        • Contact:
          • Site 0156
      • Wuhan, Hubei, China, 430022
        • Withdrawn
        • Local Institution - 0157
    • Hunan
      • Changsha, Hunan, China, 410008
        • Withdrawn
        • Local Institution - 0168
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Withdrawn
        • Local Institution - 0162
      • Suzhou, Jiangsu, China, 215006
        • Withdrawn
        • Local Institution - 0163
    • Jilin
      • Changchun, Jilin, China, 130021
        • Withdrawn
        • Local Institution - 0179
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Not yet recruiting
        • Local Institution - 0166
        • Contact:
          • Site 0166
    • Shaanxi
      • Xian, Shaanxi, China, 710068
        • Withdrawn
        • Local Institution - 0160
    • Shandong
      • Jinan, Shandong, China, 250014
        • Withdrawn
        • Local Institution - 0169
      • Qingdao, Shandong, China, 266003
        • Withdrawn
        • Local Institution - 0164
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Withdrawn
        • Local Institution - 0165
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Withdrawn
        • Local Institution - 0141
      • Ningbo, Zhejiang, China, 315010
        • Withdrawn
        • Local Institution - 0161
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Completed
        • Local Institution - 0060
      • Praha 2, Czechia, 12808
        • Withdrawn
        • Local Institution - 0045
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Withdrawn
        • Local Institution - 0009
  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Completed
        • Local Institution - 0115
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Completed
        • Local Institution - 0116
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Withdrawn
        • Local Institution - 0114
  • France
      • Paris, France, 75010
        • Active, not recruiting
        • Local Institution - 0082
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Withdrawn
        • Local Institution - 0025
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Active, not recruiting
        • Local Institution - 0063
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37032
        • Completed
        • Local Institution - 0024
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Active, not recruiting
        • Local Institution - 0094
    • Nord
      • Lille, Nord, France, 59000
        • Active, not recruiting
        • Local Institution - 0056
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Active, not recruiting
        • Local Institution - 0085
  • Germany
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Local Institution - 0037
      • Hamburg, Germany, 22081
        • Completed
        • Local Institution - 0007
      • Mutlangen, Germany, 73557
        • Completed
        • Local Institution - 0028
    • Bayern
      • Kempten, Bayern, Germany, 87439
        • Withdrawn
        • Local Institution - 0076
      • Munich, Bayern, Germany, 81675
        • Withdrawn
        • Local Institution - 0059
    • Nordrhein-Westfalen
      • Duisburg, Nordrhein-Westfalen, Germany, 47166
        • Completed
        • Local Institution - 0081
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40479
        • Active, not recruiting
        • Local Institution - 0128
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Completed
        • Local Institution - 0055
  • Greece
      • Alexandroupolis, Greece, 08100
        • Recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
    • Attikí
      • Chaidari, Attikí, Greece, 12462
        • Recruiting
        • Attikon General University Hospital
        • Contact:
          • Vasiliki Pappa, Site 0125
          • Phone Number: 00306937255084
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 10
        • Recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
  • Hong Kong
      • Hksar, Hong Kong
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
      • Shatin, Hong Kong, NT
        • Not yet recruiting
        • Local Institution - 0180
        • Contact:
          • Site 0180
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Stefania Paolini, Site 0101
          • Phone Number: +393392231941
      • Pavia, Italy, 27100
        • Withdrawn
        • Local Institution - 0067
      • Reggio Calabria, Italy, 89133
        • Withdrawn
        • Local Institution - 0053
      • Roma, Italy, 00168
        • Withdrawn
        • Local Institution - 0143
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Recruiting
        • Fondazione Policlinico Tor Vergata
        • Contact:
          • Maria Teresa Voso, Site 0061
          • Phone Number: 390620903210
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Withdrawn
        • Local Institution - 0088
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Completed
        • Local Institution - 0075
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Withdrawn
        • Local Institution - 0089
  • Japan
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
          • Masayuki Hino, Site 0124
          • Phone Number: 81666452121
    • Ehime
      • Matsuyama, Ehime, Japan, 7900024
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Not yet recruiting
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • Kitakyushu-shi, Fukuoka, Japan, 8068501
        • Recruiting
        • Japan Community Healthcare Organization Kyushu Hospital
        • Contact:
          • Ryosuke Ogawa, Site 0136
          • Phone Number: +81936415111
    • Gifu
      • Ogaki, Gifu, Japan, 503-0864
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Gunma
      • Maebashi, Gunma, Japan, 371-0821
        • Not yet recruiting
        • Local Institution - 0186
        • Contact:
          • Site 0186
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0001
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0804
        • Recruiting
        • Aiiku Hospital
        • Contact:
          • Takeshi Kondo, Site 0154
          • Phone Number: 81115632211
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
        • Recruiting
        • Local Institution - 0153
        • Contact:
          • Site 0153
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 3113117
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
      • Hitachi, Ibaraki, Japan, 317-0077
        • Not yet recruiting
        • Local Institution - 0188
        • Contact:
          • Site 0188
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Local Institution - 0135
        • Contact:
          • Site 0135
    • Tokyo
      • Itabashiku, Tokyo, Japan, 173-8610
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Completed
        • Local Institution - 0150
  • Korea, Republic of
    • Jeonranamdo
      • Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128
        • Active, not recruiting
        • Local Institution - 0058
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • Completed
        • Local Institution - 0048
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Active, not recruiting
        • Local Institution - 0036
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Active, not recruiting
        • Local Institution - 0012
    • Taegu-Kwangyǒkshi
      • Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of, 41944
        • Completed
        • Local Institution - 0051
  • Poland
      • Katowice, Poland, 40-519
        • Withdrawn
        • Local Institution - 0043
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 50-367
        • Withdrawn
        • Local Institution - 0044
    • Warmińsko-mazurskie
      • Olsztyn, Warmińsko-mazurskie, Poland, 10-228
        • Completed
        • Local Institution - 0097
  • Spain
      • Granada, Spain, 18012
        • Active, not recruiting
        • Local Institution - 0107
      • Madrid, Spain, 28006
        • Active, not recruiting
        • Local Institution - 0111
      • Orense, Spain, 32005
        • Completed
        • Local Institution - 0112
      • Oviedo, Spain, 33011
        • Completed
        • Local Institution - 0110
      • Salamanca, Spain, 37007
        • Completed
        • Local Institution - 0108
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Withdrawn
        • Local Institution - 0105
    • Catalunya [Cataluña]
      • L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08908
        • Withdrawn
        • Local Institution - 0106
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Active, not recruiting
        • Local Institution - 0109
  • Sweden
    • Skåne Län [se-12]
      • Lund, Skåne Län [se-12], Sweden, 22185
        • Withdrawn
        • Local Institution - 0117
    • Stockholms Län [se-01]
      • Stockholm, Stockholms Län [se-01], Sweden, 141 86
        • Active, not recruiting
        • Local Institution - 0118
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Withdrawn
        • Local Institution - 0113
    • Örebro Län [se-18]
      • Örebro, Örebro Län [se-18], Sweden, 701 85
        • Completed
        • Local Institution - 0119
  • Switzerland
      • Basel, Switzerland, 4031
        • Withdrawn
        • Local Institution - 0066
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Withdrawn
        • Local Institution - 0077
  • Turkey
      • Samsun, Turkey, 55270
        • Withdrawn
        • Local Institution - 0140
      • İzmir, Turkey, 35100
        • Withdrawn
        • Local Institution - 0138
    • İstanbul
      • Pendik, İstanbul, Turkey, 34899
        • Withdrawn
        • Local Institution - 0139
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center
        • Contact:
          • MIKKAEL SEKERES, Site 0137
          • Phone Number: 305-243-9974
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Advanced Research
        • Contact:
          • Sumit Sawhney, Site 0147
          • Phone Number: 954-302-3120
      • Tampa, Florida, United States, 33612
        • Withdrawn
        • Local Institution - 0095
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Withdrawn
        • Local Institution - 0173
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Local Institution - 0174
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Withdrawn
        • Rutgers Cancer Institute of New Jersey
    • New York
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology-Oncology Associates of Central New York, PC
        • Contact:
          • Ajeet Gajra, Site 0132
          • Phone Number: 315-425-3456
      • New York, New York, United States, 10065
        • Withdrawn
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Withdrawn
        • Novant Health Presbyterian Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Withdrawn
        • Local Institution - 0096
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • AHN West Penn Hospital
        • Contact:
          • Salman Fazal, Site 0073
          • Phone Number: 412-578-4355
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Withdrawn
        • Charleston Oncology, P.A.
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Shilpan Shah, Site 0086
          • Phone Number: 832-776-5668
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Guillermo Garcia-Manero, Site 0014
          • Phone Number: 713-745-3428
    • Utah
      • Salt Lake City, Utah, United States, 84112-5550
        • Withdrawn
        • Huntsman Cancer Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
          • Danielle Shafer, Site 0123
          • Phone Number: 571-472-1043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).

MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.

• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

  • Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
  • Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
  • Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
  • Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part I - Oral-Aza (Dose 1)
Drug: Oral Azacitidine
Specified dose on specified days
Other Names:
  • BMS-986345
  • Oral-Aza
  • ONUREG®
Experimental: Part I - Oral-Aza (Dose 2)
Drug: Oral Azacitidine
Specified dose on specified days
Other Names:
  • BMS-986345
  • Oral-Aza
  • ONUREG®
Experimental: Part II - Oral-Aza (RP3D)
RP3D: Recommended Phase 3 Dose
Drug: Oral Azacitidine
Specified dose on specified days
Other Names:
  • BMS-986345
  • Oral-Aza
  • ONUREG®
Experimental: Part II - Placebo
Drug: Placebo for Oral Azacitidine
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Time Frame: 6 cycles plus 28 days (up to 24 weeks)
Phase 2
6 cycles plus 28 days (up to 24 weeks)
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Time Frame: Up to 24 weeks
Phase 2 and 3
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles
Time Frame: Up to 24 weeks

Phase 2 and Phase 3

Overall Response is defined as complete response (CR), partial remission (PR), marrow complete response (mCR), hematologic improvement-erythroid response (HI-E), hematologic improvement-platelet response (HI-P), or hematologic improvement-neutrophil response (HI-N) as per IWG 2006 criteria
Up to 24 weeks
Number of participants who achieved 84-day packed red blood cells transfusion independence (pRBC-TI)
Time Frame: Up to 32 weeks
Phase 2 and Phase 3
Up to 32 weeks
pRBC-TI duration
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
Number of participants who achieve 84 day platelet transfusion independence (PLT-TI) within 6 cycles
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
PLT-TI duration
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
Number of participants who achieved pRBC transfusion reduction
Time Frame: Over the course of the study, an average of 1 year
Phase 3
Over the course of the study, an average of 1 year
pRBC transfusion reduction duration
Time Frame: Over the course of the study, an average of 1 year
Phase 3
Over the course of the study, an average of 1 year
CR duration
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
Best OR
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
OR duration
Time Frame: Over the course of the study, an average of 1 year
Phase 2 and Phase 3
Over the course of the study, an average of 1 year
Overall Survival (OS)
Time Frame: Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Phase 3
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Event-free Survival (EFS)
Time Frame: Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Phase 3
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Time to acute myeloid leukemia (AML)
Time Frame: Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Phase 3
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Time to subsequent therapy
Time Frame: Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Phase 3
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Iron parameters measured from blood
Time Frame: Over the course of the study, an average of 1 year
Phase 3
Over the course of the study, an average of 1 year
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Time Frame: Up to end of treatment/early termination, an average of 1 year
Phase 3
Up to end of treatment/early termination, an average of 1 year
Summary statistics for Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales and subscales at each assessment point for each treatment arm
Time Frame: Up to end of treatment/early termination, an average of 1 year
Phase 3
Up to end of treatment/early termination, an average of 1 year
Summary statistics for Quality of Life in Myelodysplasia Scale (QUALMS) scales and subscales at each assessment point for each treatment arm
Time Frame: Up to end of treatment/early termination, an average of 1 year
Phase 3
Up to end of treatment/early termination, an average of 1 year
Summary statistics for the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scales and subscales at each assessment point for each treatment arm
Time Frame: Up to end of treatment/early termination, an average of 1 year
Phase 3
Up to end of treatment/early termination, an average of 1 year
Number of participants with healthcare resource use associated with the investigational product (IP)
Time Frame: Over the course of the study, an average of 1 year
Phase 3
Over the course of the study, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

July 29, 2026

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA055-026
  • U1111-1276-5463 (Other Grant/Funding Number: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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