Non-Hodgkin Lymphoma
Conditions
Keywords
CC-122, Avadomide, BMS-986381, Non-Hodgkin Lymphoma, Diffuse large B cell lymphoma, Follicular lymphoma, Chronic lymphocytic leukemia, Multiple myeloma
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.
Interventions
DRUGCC-122
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Japan, Netherlands, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed