A Rollover Study of CC-122

May 6, 2026 updated by: Bristol-Myers Squibb

Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating CC-122

The purpose of the study is to provide CC-122 treatment to participants who have been receiving treatment in other CC-122 clinical trials investigating CC-122 for more than 5 years (CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • 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 Locations

  • France
      • Bordeaux, France, 33076
        • Local Institution - 300
      • Marseille, France, 13273
        • Local Institution - 301
  • Japan
    • Tokyo
      • Koto-ku, Tokyo, Japan, 1358550
        • Local Institution - 500
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Local Institution - 400
  • United States
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 100
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 101
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Local Institution - 102

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

Key Inclusion Criteria:

  • Participant who is currently receiving CC-122 on another CC-122 clinical trial that has met its primary and secondary endpoints.
  • Participant who has participated in previous CC-122 protocol (including CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), and is deemed by the investigator to be deriving benefit from CC-122 as defined by the previous protocol.
  • Participant who is able to tolerate study therapy and has not yet experienced progressive disease or any treatment discontinuation criteria of the Parent Study.

Key Exclusion Criteria:

  • Participant is not eligible for CC-122 treatment as per the Parent Study.
  • Participants not receiving clinical benefit as assessed by the investigator. Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the participant.
  • Women who are breastfeeding.

Note: 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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CC-122 and Dexamethasone
Drug: Dexamethasone
Specified dose on specified days
Drug: CC-122
Specified dose on specified days
Other Names:
  • Avadomide
  • BMS-986381

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Number of deaths for participants who received at least 1 dose of CC-122
Time Frame: Up to approximately 3 years
Up to approximately 3 years

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)

April 11, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA092-1000
  • 2022-501855-97 (EudraCT Number)
  • U1111-1282-2472 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • 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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