A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

April 3, 2024 updated by: Celgene

A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy).

The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy.

The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 or the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and NHL.

Part B Cohort B will further evaluate the potential effects of food on the PK and safety of CC-99282.

Study Type

Interventional

Enrollment (Estimated)

438

Phase

  • Phase 2
  • Phase 1

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

Study Contact Backup

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Not yet recruiting
        • Local Institution - 253
        • Contact:
          • Site 253
      • Buenos Aires, Argentina, C1426ANZ
        • Withdrawn
        • Local Institution - 250
      • Cordoba, Argentina, 5016
        • Withdrawn
        • Local Institution - 252
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman
        • Contact:
          • Maria Clavijo, Site 255
          • Phone Number: 5491132613344
      • Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Withdrawn
        • Local Institution - 251
      • Pilar, Buenos Aires, Argentina, 1629
        • Not yet recruiting
        • Local Institution - 254
        • Contact:
          • Site 254
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Local Institution - 701
        • Contact:
          • Site 701
      • St. Polten, Austria, 3100
        • Recruiting
        • Local Institution - 704
        • Contact:
          • Site 704
      • Vienna, Austria, 1090
        • Recruiting
        • Local Institution - 703
        • Contact:
          • Site 703
  • Belgium
      • Edegem, Belgium, 2650
        • Withdrawn
        • Local Institution - 903
      • Leuven, Belgium, 3000
        • Withdrawn
        • Local Institution - 901
      • Leuven, Belgium, 3000
        • Completed
        • Local Institution - 902
  • Brazil
      • São Paulo, Brazil, 1246000
        • Recruiting
        • Local Institution - 452
        • Contact:
          • Site 452
      • São Paulo, Brazil, 04501-000
        • Recruiting
        • Instituto D'or de Pesquisa e Ensino
        • Contact:
          • Eduardo Magalhaes Rego, Site 451
          • Phone Number: +551636022888
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital Sao Lucas da PUCRS
        • Contact:
          • Mariza Schaan, Site 453
          • Phone Number: 55 5133203319
    • Sp
      • Sao Paulo, Sp, Brazil, 05651-901
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
          • Guilherme Fleury Perini, Site 450
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z2
        • Withdrawn
        • Local Institution - 203
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • John Kuruvilla, Site 201
          • Phone Number: 4169464501ext2821
  • Chile
      • Santiago, Chile, 7591046
        • Withdrawn
        • Local Institution - 0909
      • Santiago, Chile, 838-0455
        • Withdrawn
        • Local Institution - 351
    • Metropolitana
      • Recoleta, Metropolitana, Chile, 842 0383
        • Recruiting
        • Bradford Hill
        • Contact:
          • Sergio Portiño, Site 355
          • Phone Number: 56998467083
      • Santiago, Metropolitana, Chile, 8320000
        • Recruiting
        • Local Institution - 352
        • Contact:
          • Site 352
      • Santiago, Metropolitana, Chile, 7500921
        • Recruiting
        • Fundacion Oncologia Arturo Lopez Perez
        • Contact:
          • Raimundo Gazitua, Site 353
          • Phone Number: +56984290128
    • Metropolitana DE Santiago
      • Santiago, Metropolitana DE Santiago, Chile, 7580206
        • Recruiting
        • Clínica Inmunocel
        • Contact:
          • Alejandro Berkovits, Site 354
          • Phone Number: 997890202
    • RM
      • Santiago, RM, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión
        • Contact:
          • Marcelo Garrido, Site 350
  • China
      • Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Huiqiang Huang, Site 659
          • Phone Number: 8613808885154
      • Guangzhou, China, 510515
        • Withdrawn
        • Local Institution - 658
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing, Site 653
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Withdrawn
        • Local Institution - 656
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Wenyu Li, Site 657
          • Phone Number: 86-13924196915
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Withdrawn
        • Local Institution - 652
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou, Site 655
    • Hubei
      • Wuhan Shi, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Huijing Wu, Site 660
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
          • Xiaojing Yan, Site 662
          • Phone Number: 13889128302
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • wei yang, Site 663
          • Phone Number: 18940251012
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Local Institution - 650
        • Contact:
          • Site 650
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Lihua Qiu, Site 651
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310052
        • Withdrawn
        • Local Institution - 654
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Judit Meszaros Joergensen, Site 602
          • Phone Number: +4578465130
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Local Institution - 601
        • Contact:
          • Site 601
      • Vejle, Denmark, 7100
        • Recruiting
        • Local Institution - 603
        • Contact:
          • Site 603
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
        • Contact:
          • Fontanet Bijou, Site 407
          • Phone Number: 33556333333
      • Creteil, France, 94010
        • Recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Corinne Haioun, Site 403
          • Phone Number: +33149812151
      • Lillie Cedex, France, 59037
        • Recruiting
        • CHRU de Lille - Hopital Claude Huriez
        • Contact:
          • Franck Morschhauser, Site 406
          • Phone Number: 33320445713
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier - Hôpital St Eloi
        • Contact:
          • Guillaume Cartron, Site 409
          • Phone Number: +33675926918
      • Montpellier CEDEX 5, France, 34295
        • Withdrawn
        • Local Institution - 0904
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Catherine Thieblemont, Site 405
          • Phone Number: 33142499236
      • Pierre-Benite CEDEX, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon-Sud
        • Contact:
          • Emmanuel Bachy, Site 402
          • Phone Number: 33478862286
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
        • Contact:
          • Fabrice JARDIN, Site 404
      • Toulouse, France, 31200
        • Recruiting
        • Institut Claudius Regaud, IUCT-Oncopole
        • Contact:
          • Pierre Bories, Site 408
          • Phone Number: 33531156514
      • Villejuif CEDEX, France, 94805
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Vincent Ribrag, Site 401
          • Phone Number: 33142114507
  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Local Institution - 150
        • Contact:
          • Site 150
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Local Institution - 151
        • Contact:
          • Site 151
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Local Institution - 152
        • Contact:
          • Site 152
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Local Institution - 501
        • Contact:
          • Site 501
      • Bologna, Italy, 40138
        • Recruiting
        • Local Institution - 504
        • Contact:
          • Site 504
      • Milano, Italy, 20162
        • Recruiting
        • Local Institution - 503
        • Contact:
          • Site 503
      • Napoli, Italy, 80131
        • Recruiting
        • Local Institution - 502
        • Contact:
          • Site 502
      • Pavia, Italy, 27100
        • Recruiting
        • Local Institution - 506
        • Contact:
          • Site 506
      • Rozzano, Italy, 20089
        • Withdrawn
        • Local Institution - 505
      • Verona, Italy, 37134
        • Withdrawn
        • Local Institution - 507
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Won-Sik Lee, Site 553
          • Phone Number: 82-51-890-8849
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Sung-Soo Yoon, Site 551
          • Phone Number: +821047546706
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Won-Seog Kim, Site 550
          • Phone Number: 8223410654800000
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Local Institution - 552
        • Contact:
          • Site 552
  • Spain
      • Badalona (Barcelona), Spain, 08916
        • Recruiting
        • Local Institution - 306
        • Contact:
          • Site 306
      • Barcelona, Spain, 08035
        • Recruiting
        • Local Institution - 301
        • Contact:
          • Site 301
      • Madrid, Spain, 28046
        • Recruiting
        • Local Institution - 304
        • Contact:
          • Site 304
      • Madrid, Spain, 28040
        • Recruiting
        • Local Institution - 302
        • Contact:
          • Site 302
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Antonio Rueda-Domínguez, Site 303
          • Phone Number: +34951032467 00 000
      • Salamanca, Spain, 37007
        • Recruiting
        • Local Institution - 305
        • Contact:
          • Site 305
  • United Kingdom
      • Belfast Northern Ireland, United Kingdom, BT9 7AB
        • Withdrawn
        • Local Institution - 0905
      • Belfast Northern Ireland, United Kingdom, BT9 7AB
        • Withdrawn
        • Local Institution - 805
      • Edinburgh Scotland, United Kingdom, EH4 2XU
        • Recruiting
        • Local Institution - 802
        • Contact:
          • Site 802
      • Southhampton, United Kingdom, SO01 6YD
        • Recruiting
        • Local Institution - 803
        • Contact:
          • Site 803
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona - Scottsdale
        • Contact:
          • Javier Munoz, Site 109
          • Phone Number: 480-301-8000
    • California
      • La Jolla, California, United States, 92093
        • Withdrawn
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90048-1804
        • Not yet recruiting
        • Local Institution - 114
        • Contact:
          • Site 114
      • Orange, California, United States, 92848
        • Withdrawn
        • University of California, Irvine
      • Whittier, California, United States, 90603
        • Withdrawn
        • Oncology Institute of Hope and Innovation
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville
        • Contact:
          • Muhamad Alhaj Moustafa, Site 111
          • Phone Number: 904-953-2000
      • Tampa, Florida, United States, 32207
        • Recruiting
        • H Lee Moffitt Cancer Center
        • Contact:
          • Julio Chavez, Site 102
          • Phone Number: 813-745-8172
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Withdrawn
        • The University of Kansas - Clinical Research Center
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • The University of Kansas - Clinical Research Center
        • Contact:
          • Marc Hoffmann, Site 108
          • Phone Number: 913-574-2650
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Withdrawn
        • University of Maryland at Baltimore
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Grzegorz Nowakowski, Site 107
          • Phone Number: 507-284-2511
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic in Rochester, Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Completed
        • Washington University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Local Institution - 103
    • New York
      • Mineola, New York, United States, 11501
        • Withdrawn
        • Perlmutter Cancer Center at NYU Langone Hospital-Long Island
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Loretta Nastoupil, Site 101
          • Phone Number: 713-745-4017

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:

  • History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

  • Life expectancy ≤ 2 months
  • Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
  • Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
  • Impaired cardiac function or clinically significant cardiac disease

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose Escalation
Drug: CC-99282
Specified dose on specified days
Other Names:
  • BMS-986369
Experimental: Part B: Dose Expansion
Drug: Rituximab
Specified dose on specified days
Drug: CC-99282
Specified dose on specified days
Other Names:
  • BMS-986369
Drug: Obinutuzumab
Specified dose on specified days
Drug: Tafasitamab
Specified dose on specified days
Drug: Valemetostat
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: Up to 28 days in Cycle 1
Up to 28 days in Cycle 1
Maximum tolerated dose (MTD)
Time Frame: Up to 28 days in cycle 1
Up to 28 days in cycle 1
Incidence of Adverse Events (AEs)
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with laboratory abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with vital sign abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with physical examination abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Objective response rate (ORR)
Time Frame: Up to approximately 6 years

Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Time to response (TTR)
Time Frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Duration of response (DoR)
Time Frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Progression free survival (PFS)
Time Frame: Up to approximately 6 years

Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Overall survival (OS)
Time Frame: Up to approximately 6 years

Time from first dose of CC-99282 to death from any cause

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
ORR
Time Frame: Up to approximately 4 years

Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).

Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
TTR
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
DOR
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
PFS
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
OS
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years

Collaborators and Investigators

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

Sponsor

Celgene

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)

May 20, 2019

Primary Completion (Estimated)

April 17, 2026

Study Completion (Estimated)

April 18, 2027

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-99282-NHL-001
  • U1111-1224-5399 (Registry Identifier: WHO)
  • 2018-003235-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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