A Rollover Study of CC-122

Trial Title: A Rollover Study of CC-122

NCT ID: NCT05688475

Condition: Non-Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Dexamethasone

Conditions: Keywords:
CC-122
Avadomide
BMS-986381
Non-Hodgkin Lymphoma
Diffuse large B cell lymphoma
Follicular lymphoma
Chronic lymphocytic leukemia
Multiple myeloma

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CC-122
Description: Specified dose on specified days
Arm group label: CC-122 and Dexamethasone

Other name: Avadomide

Other name: BMS-986381

Intervention type: Drug
Intervention name: Dexamethasone
Description: Specified dose on specified days
Arm group label: CC-122 and Dexamethasone

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Local Institution - 100

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: Local Institution - 101

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: Local Institution - 102

Address:
City: Madison
Zip: 53792
Country: United States

Facility:
Name: Local Institution - 300

Address:
City: Bordeaux
Zip: 33076
Country: France

Facility:
Name: Local Institution - 301

Address:
City: Marseille cedex
Zip: 13273
Country: France

Facility:
Name: Local Institution - 500

Address:
City: Koto-ku
Zip: 1358550
Country: Japan

Facility:
Name: Local Institution - 400

Address:
City: Amsterdam
Zip: 1105
Country: Netherlands

Start date: April 11, 2023

Completion date: February 25, 2026

Lead sponsor:
Agency: Bristol-Myers Squibb
Agency class: Industry

Source: Bristol-Myers Squibb

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05688475
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT05688475.html