NCT04717414

Brief Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
313

participants targeted

Target at P50-P75 for phase_3

Timeline
77mo left

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach
25 countries

180 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Feb 2021Aug 2032

First Submitted

Initial submission to the registry

December 29, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2032

Expected
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

December 29, 2020

Last Update Submit

July 7, 2025

Conditions

Keywords

LuspaterceptACE-536Myeloproliferative NeoplasmMyelofibrosisJAK2Red blood cell transfusionPost-ET MFPost-PV MFReblozylAnemia

Outcome Measures

Primary Outcomes (1)

  • Red blood cell-transfusion independence (RBC-TI) ≥ 12 weeks (RBC-TI 12)

    Proportion of subjects who become RBC-transfusion free over any consecutive 12-week period starting within the first 24 weeks.

    Up to 24 weeks

Secondary Outcomes (15)

  • Red blood cell-transfusion independence ≥ 16 weeks (RBC-TI 16)

    Up to 24 weeks

  • Duration of Red blood cell-transfusion independence (RBC-TI 12)

    Up to end of treatment, approximately 3 years

  • Reduction of transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12-week period

    Up to 24 weeks

  • Duration of reduction in transfusion burden

    Up to end of treatment, approximately 3 years

  • Red blood cell-transfusion independence ≥ 12 weeks in the treatment period (RBC-TI 12/TP)

    Up to end of treatment, approximately 3 years

  • +10 more secondary outcomes

Study Arms (2)

Experimental Arm: Luspatercept (ACE-536)

EXPERIMENTAL

Luspatercept will be given to participants via subcutaneous injection (administered on Day 1 of each 21-day treatment cycle)

Drug: ACE-536

Control Arm: Placebo

PLACEBO COMPARATOR

Placebo starting dose with volume equivalent to experimental arm subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)

Other: Placebo

Interventions

Subcutaneous Injection

Also known as: Luspatercept, BMS-986346
Experimental Arm: Luspatercept (ACE-536)
PlaceboOTHER

Subcutaneous Injection

Control Arm: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Subject is ≥18 years of age at the time of signing the ICF.
  • Subject has a diagnosis of PMF according to the 2016 World Health Organization (WHO) criteria or diagnosis of post-ET or post-PV MF according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report.
  • Subject is requiring RBC transfusions as defined as:.
  • i) Average RBC-transfusion frequency: 4 to 12 RBC units/12 weeks immediately up to randomization. There must be no interval \> 6 weeks (42 days) without ≥ 1 RBC transfusion.
  • ii) RBC transfusions are scored in determining eligibility when given for treatment of:.
  • A. Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb ≤ 9.5 g/dL or.
  • B. Asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL.
  • iii) RBC transfusions given for worsening of anemia due to bleeding or infections are not scored in determining eligibility.
  • \- Subjects on continuous (eg, absent of dose interruptions lasting ≥ 2 consecutive weeks) JAK2 inhibitor therapy as approved in the country of the study site for the treatment for MPN-associated MF as part of their standard-of-care therapy for at least 32 weeks, on stable daily dose for at least 16 weeks immediately up to the date of randomization and anticipated to be on a stable daily dose of that JAK2 inhibitor for at least 24 weeks after randomization.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
  • A female of childbearing potential (FCBP) for this study is defined as a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (eg, has had menses at any time in the preceding 24 consecutive months). Females of childbearing potential (FCBP)participating in the study must:.
  • i) Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the study, and after end of IP. This applies even if the subject practices true abstinence\* from heterosexual contact.
  • ii) Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception\*\* without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) after discontinuation of study therapy.
  • \- Male subjects must: Practice true abstinence\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential\*\* while participating in the study, during dose interruptions and for at least 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy.
  • i) True abstinence is acceptable when it is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.\].
  • +3 more criteria

You may not qualify if:

  • The presence of any of the following will exclude a subject from randomization:.
  • Subject with anemia from cause other than MPN-associated MForJAK2 inhibitor therapy (eg, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infection, or any type of known clinically significant bleeding or sequestration).
  • Subject use of hydroxyurea, immunomodulatory compounds such as pomalidomide, thalidomide, ESAs, androgenic steroids or other drugs with potential effects on hematopoiesis ≤ 8 weeks immediately up to the date of randomization.
  • i) Systemic corticosteroids are permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone for the 4 weeks immediately up to randomization.
  • ii) Iron chelation therapy (ICT) is permitted providing the subject is receiving a stable dose for the 8 weeks immediately up to randomization.
  • \- Subject with any of the following laboratory abnormalities at screening:.
  • i) Neutrophils: \< 1 x 10\^9/L.
  • ii) White blood count (WBC): \> 100 x 10\^9/L.
  • iii) Platelets: the lowest allowable level as approved for the concomitant JAK2 inhibitor but not \< 25 x 10\^9/L or \> 1000 x 10\^9/L.
  • iv) Peripheral blood myeloblasts:\> 5%.
  • v) Estimated glomerular filtration rate:\< 30 mL/min/1.73 m2 (via the 4-variable modification of diet in renal disease \[MDRD\] formula) or nephrotic subjects (eg, urine albumin-to-creatinine ratio \> 3500 mg/g).
  • vi) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):\> 3.0 x upper limit of normal (ULN).
  • vii) Direct bilirubin: ≥ 2 x ULN.
  • A. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (eg, ineffective erythropoiesis).
  • Subject with uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, that is not resolved at the time of randomization.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (185)

Local Institution - 110

Los Angeles, California, 90095, United States

Location

Local Institution - 135

Orlando, Florida, 32804, United States

Location

Local Institution - 133

Plantation, Florida, 33322, United States

Location

Local Institution - 112

Chicago, Illinois, 60612, United States

Location

Local Institution - 124

Lexington, Kentucky, 40536-0293, United States

Location

Local Institution - 114

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 108

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601-2191, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 130

Knoxville, Tennessee, 37920, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution - 119

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 172

Ciudad Autónoma de BuenosAires, Buenos Aires, C1280AEB, Argentina

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AX, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB, Argentina

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Gosford Hospital

Gosford, 2250, Australia

Location

Royal Hobart Hospital

Hobart, 7000, Australia

Location

Local Institution - 272

Graz, 8036, Austria

Location

Krankenhaus der Elisabethinen Linz, I Interne Abteilung

Linz, 4020, Austria

Location

Local Institution - 271

Vienna, 1090, Austria

Location

Local Institution - 274

Vienna, 1140, Austria

Location

Local Institution - 318

Bruges, 8000, Belgium

Location

Local Institution - 312

Brussels, 1200, Belgium

Location

Local Institution - 313

Hasselt, 3500, Belgium

Location

Uz Leuven

Leuven, 3000, Belgium

Location

Local Institution - 319

Liège, 4000, Belgium

Location

Local Institution - 316

Roeselare, 8800, Belgium

Location

Local Institution - 315

Verviers, 4800, Belgium

Location

Cliniques Universitaires UCL de Mont-Godine

Yvoir, 5530, Belgium

Location

Local Institution - 181

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 179

Edmonton, Alberta, T6G 2S2, Canada

Location

Local Institution - 183

Vancouver, British Columbia, V6Z 2A5, Canada

Location

University Hospital - London Health Sciences Centre

London, Ontario, N6C 6B5, Canada

Location

Local Institution - 180

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 177

Montreal, Quebec, H1T 2M4, Canada

Location

Sir Mortimer B. Davis - Jewish Genl

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 176

Sherbrooke, Quebec, J1H5N4, Canada

Location

IC La Serena Research

La Serena, Coquimbo Region, 1720430, Chile

Location

Local Institution - 192

Las Condes, Metropolitana de Santiago, 7560742, Chile

Location

Local Institution - 193

Santiago, 7500587, Chile

Location

Nanfang Hospital of Southern Medical University

Guangzhou, GD, 510515, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Location

Xiangya Hospital Central-South University

Changsha, Hunan, 410008, China

Location

Local Institution - 804

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 818

Nantong, Jiangsu, 226001, China

Location

Local Institution - 820

Nanchang, Jiangxi, 330006, China

Location

Nanchang University - The Second Affiliated Hospital

Nanchang, Jiangxi, 330008, China

Location

Local Institution - 821

Qingdao, Shandong, 0, China

Location

Local Institution - 816

Taiyuan, Shanxi, 030001, China

Location

The Second Affiliated Hospital Of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

Beijing Peking Union Medical College Hospital

Beijing, 100730, China

Location

Local Institution - 802

Changchun, 130021, China

Location

Guangdong General Hospital

Guangzhou, 510030, China

Location

The First Affiliated Hospital Of Harbin Medical University

Harbin, 150081, China

Location

Local Institution - 809

Shanghai, 200025, China

Location

Local Institution - 801

Shanghai, 200233, China

Location

Local Institution - 811

Suzhou, 215006, China

Location

Local Institution - 800

Tianjin, 300041, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Local Institution - 810

Zhengzhou, 0, China

Location

Local Institution - 161

Medellín, Antioquia, 50034, Colombia

Location

Local Institution - 163

Bogotá, Distrito Capital de Bogotai, 111511, Colombia

Location

Local Institution - 162

Floridablanca, Soto, 681002, Colombia

Location

Local Institution - 341

Prague, 128 08, Czechia

Location

Local Institution - 331

Angers, 49033, France

Location

Local Institution - 333

Clermont-Ferrand, 63000, France

Location

Local Institution - 324

Créteil, 94010, France

Location

Chu De Grenoble

Grenoble, 38043, France

Location

Local Institution - 327

Lille, 59037, France

Location

Local Institution - 332

Lyon, 69008, France

Location

CHU de Nice Archet I

Nice, 06202, France

Location

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Nîmes, 30029, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Groupe Hospitalier Sud Hopital Haut Leveque USN

Pessac, 33604, France

Location

CHU La Miletrie

Poitiers, 86021, France

Location

ICANS Institut de cancerologie Strasbourg Europe

Strasbourg, 67200, France

Location

Local Institution - 330

Toulouse, 31059, France

Location

Unviversitatsklinikum Aachen

Aachen, 52074, Germany

Location

Stauferklinikum Schwab. Gmund

Baden-Warttemberg, 73557, Germany

Location

Local Institution - 299

Düsseldorf, 40225, Germany

Location

Universitatsklinikum Halle Saale

Halle, 06120, Germany

Location

Local Institution - 300

Hamburg, 22081, Germany

Location

Universitaetsklinikum Jena

Jena, 07740, Germany

Location

Local Institution - 297

Leipzig, 04103, Germany

Location

Local Institution - 301

Mannheim, 68167, Germany

Location

Johannes Wiesling Klinikum Minden

Minden, 32429, Germany

Location

Local Institution - 387

Pátrai, Achaia, 264 43, Greece

Location

Local Institution - 383

Alexandroupoli, 08100, Greece

Location

Evangelismos General Hospital of Athens

Athens, 10676, Greece

Location

Local Institution - 386

Athens, 11 527, Greece

Location

Attikon University General Hospital

Athens, 12464, Greece

Location

University General Hospital of Patras

Rio Patras, 26500, Greece

Location

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, 57010, Greece

Location

Local Institution - 661

Hong Kong, 0, Hong Kong

Location

Prince of Wales Hospital the Chinese University of Hong Kong

Shatin, 0, Hong Kong

Location

Local Institution - 462

Budapest, 1096, Hungary

Location

Local Institution - 463

Győr, 9023, Hungary

Location

Cork University Hospital

Cork, T12 DFK4, Ireland

Location

Mater Misercordiae Hospital

Dublin, 7, Ireland

Location

St James Hospital

Dublin, Dublin 8, Ireland

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, 64239, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Shamir Medical Center - Assaf Harofeh

Ẕerifin, 70300, Israel

Location

IRCCS - Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori" (IRST)

Meldola (fc), Fc, 47014, Italy

Location

Local Institution - 250

Ancona, 60126, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Asst Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Local Institution - 246

Napoli Campania, 80131, Italy

Location

A.O.U. Maggiore della Carit

Novara, 28100, Italy

Location

Azienda Ospedaliera Di Padova

Padua, 35128, Italy

Location

Local Institution - 248

Pisa, 56100, Italy

Location

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Reggio Calabria, 89124, Italy

Location

Azienda Policlinico Universitario Umberto I

Roma, 00100, Italy

Location

Local Institution - 251

Roma, 00189, Italy

Location

Local Institution - 249

Roma, 144, Italy

Location

Local Institution - 245

Terni, 05100, Italy

Location

Local Institution - 259

Torino, 10126, Italy

Location

Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

Varese, 21100, Italy

Location

Centro Ricerche Cliniche di Verona S.r.l.

Verona, 37134, Italy

Location

The Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Nagasaki, 8528511, Japan

Location

Kindai University Hospital- Osakasayama Campus

Sayama, Osaka, 5898511, Japan

Location

Local Institution - 701

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Local Institution - 709

Chūō, Yamanashi, 409-3898, Japan

Location

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

Location

Local Institution - 713

Bunkyō City, 113-8677, Japan

Location

Tokai University Hospital

Isehara City, Kanagawa, 259-1193, Japan

Location

Local Institution - 717

Kamakura, 247-8533, Japan

Location

Kameda General Hospital

Kamogawa, 296-8602, Japan

Location

Local Institution - 706

Maebashi, 371-8511, Japan

Location

University of Miyazaki Hospital

Miyazaki, 889-1692, Japan

Location

Osaka Metropolitan university Hospital

Osaka, 545-8586, Japan

Location

Ogaki Municipal Hospital

Ōgaki, 503-8502, Japan

Location

Local Institution - 708

Sapporo, 003-0006, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku, 162-8666, Japan

Location

Local Institution - 710

Shinjyuku-ku, 160-0023, Japan

Location

Toyohashi Municipal Hospital

Toyohashi, 441-8570, Japan

Location

Local Institution - 551

Saida, South, 652, Lebanon

Location

Local Institution - 550

Badaro Beirut, 11072280, Lebanon

Location

Local Institution - 552

Beirut, 11-3288, Lebanon

Location

Local Institution - 436

Gdansk, 80-952, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, 93-510, Poland

Location

Local Institution - 433

Poznan, 61-696, Poland

Location

Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

Wałbrzych, 58-309, Poland

Location

Local Institution - 435

Wroclaw, 50367, Poland

Location

Local Institution - 395

Craiova, Dolj, 200143, Romania

Location

Onco Card SRL

Brasov, 500052, Romania

Location

Local Institution - 391

Bucharest, 022328, Romania

Location

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Local Institution - 500

Moscow, 125284, Russia

Location

Local Institution - 503

Saint Petersburg, 197022, Russia

Location

Local Institution - 502

Saint Petersburg, 197341, Russia

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun-Gun, 58128, South Korea

Location

Local Institution - 643

Seongnam-si, 13620, South Korea

Location

Local Institution - 647

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul - Saint Mary's Hospital

Seoul, 06591, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujol ICO Badalona

Barcelona, 08916, Spain

Location

Local Institution - 208

Granada, 18014, Spain

Location

Hospital Universitario De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35012, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

Location

Local Institution - 202

Palma de Mallorca, 7120, Spain

Location

Universitario de Salamanca - Hospital Clinico

Salamanca, 37007, Spain

Location

Complejo Hospitalario Universitario De Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario De Valencia

Valencia, 46010, Spain

Location

Nottingham City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust

Boston, PE21 9QS, United Kingdom

Location

Churchhill Hospital

Oxford, OX3 7LI, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Myeloproliferative DisordersPrimary MyelofibrosisAnemia

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 22, 2021

Study Start

February 25, 2021

Primary Completion

May 26, 2025

Study Completion (Estimated)

August 18, 2032

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations