Back to resultsA Rollover Study of CC-122
Primary Purpose
Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-122
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring CC-122, Avadomide, BMS-986381, Non-Hodgkin Lymphoma, Diffuse large B cell lymphoma, Follicular lymphoma, Chronic lymphocytic leukemia, Multiple myeloma
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.
Sites / Locations
- Weill Medical College Of Cornell UniversityRecruiting
- Sarah Cannon Research Institute
- University of Wisconsin Carbone Cancer CenterRecruiting
- Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
- Institut Paoli Calmette Hematologie
- Local Institution - 500
- Local Institution - 400
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CC-122 and Dexamethasone
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
Number of deaths for participants who received at least 1 dose of CC-122
Secondary Outcome Measures
Full Information
NCT ID
NCT05688475
First Posted
January 10, 2023
Last Updated
October 24, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05688475
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
February 25, 2026 (Anticipated)
Study Completion Date
February 25, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
CC-122, Avadomide, BMS-986381, Non-Hodgkin Lymphoma, Diffuse large B cell lymphoma, Follicular lymphoma, Chronic lymphocytic leukemia, Multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CC-122 and Dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-122
Other Intervention Name(s)
Avadomide, BMS-986381
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
Time Frame
Up to approximately 3 years
Title
Number of deaths for participants who received at least 1 dose of CC-122
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Weill Medical College Of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Niesvizky, Site 100
Phone
646-258-0156
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Flinn, Site 101
Phone
615-320-5090
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaishalee Kenkre, Site 102
Phone
608-263-1836
Facility Name
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Paoli Calmette Hematologie
City
Marseille cedex
ZIP/Postal Code
13273
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 500
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Individual Site Status
Completed
Facility Name
Local Institution - 400
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 400
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Rollover Study of CC-122
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