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NCT Number: NCT05688475

A Rollover Study of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-122

Drug

Specified dose on specified days

Other names: Avadomide, BMS-986381

Dexamethasone

Drug

Specified dose on specified days

Primary outcomes

  1. 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

  2. Number of deaths for participants who received at least 1 dose of CC-122

    Time frame: Up to approximately 3 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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