A Rollover Study of CC-122

NCT05688475 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA092-10002022-501855-97U1111-1282-2472
• Study Type: interventional
• Target: 12
• Locations: 4 countries
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

CC-122 and Dexamethasone

EXPERIMENTAL

Drug: CC-122; Drug: Dexamethasone

Interventions

CC-122 DRUG

Specified dose on specified days

Also known as: Avadomide, BMS-986381

CC-122 and Dexamethasone

Dexamethasone DRUG

Specified dose on specified days

CC-122 and Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Local Institution - 100

New York, New York, 10065, United States

Location

Local Institution - 101

Nashville, Tennessee, 37203, United States

Location

Local Institution - 102

Madison, Wisconsin, 53792, United States

Location

Local Institution - 300

Bordeaux, 33076, France

Location

Local Institution - 301

Marseille, 13273, France

Location

Local Institution - 500

Koto-ku, Tokyo, 1358550, Japan

Location

Local Institution - 400

Amsterdam, 1105, Netherlands

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma

Interventions

3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 18, 2023
• Study Start: April 11, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

FR (2); NL (1); JP (1); US (3)