Clinical trial NCT05688475: A Rollover Study of CC-122
Official title: Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating CC-122
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-Hodgkin Lymphoma
Keywords: CC-122
Avadomide
BMS-986381
Non-Hodgkin Lymphoma
Diffuse large B cell lymphoma
Follicular lymphoma
Chronic lymphocytic leukemia
Multiple myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
timeFrame: Up to approximately 3 years
measure: Number of deaths for participants who received at least 1 dose of CC-122
timeFrame: Up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Local Institution - 100
state: New York
city: Nashville
country: United States
facility: Local Institution - 101
state: Tennessee
city: Madison
country: United States
facility: Local Institution - 102
state: Wisconsin
city: Bordeaux
country: France
facility: Local Institution - 300
city: Marseille cedex
country: France
facility: Local Institution - 301
city: Koto-ku
country: Japan
facility: Local Institution - 500
state: Tokyo
city: Amsterdam
country: Netherlands
facility: Local Institution - 400
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: