NCT05688475

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2023

Typical duration for phase_1

Geographic Reach
4 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

January 10, 2023

Last Update Submit

October 7, 2025

Conditions

Non-Hodgkin Lymphoma

Keywords

CC-122AvadomideBMS-986381Non-Hodgkin LymphomaDiffuse large B cell lymphomaFollicular lymphomaChronic lymphocytic leukemiaMultiple 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-122Drug: Dexamethasone

Interventions

CC-122DRUG

Specified dose on specified days

Also known as: Avadomide, BMS-986381
CC-122 and Dexamethasone
DexamethasoneDRUG

Specified dose on specified days

CC-122 and Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellMultiple Myeloma

Interventions

3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dioneDexamethasone

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, 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

February 25, 2026

Study Completion

February 25, 2026

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Locations

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