A Rollover Study of CC-122

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05688475

Collaborator

(none)

Enrollment

Arm

35.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma	Drug: CC-122 Drug: Dexamethasone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Feb 18, 2026

Anticipated Study Completion Date :

Feb 18, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: CC-122 and Dexamethasone

Drug: CC-122

Specified dose on specified days

Other Names:

Avadomide

BMS-986381

Drug: Dexamethasone

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122 [Up to approximately 3 years]
Number of deaths for participants who received at least 1 dose of CC-122 [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.