Clinical Trials

Numerous early-phase clinical trials—encompassing Phase 1, Phase 2, and combined Phase 1/2 studies—have evaluated avadomide (CC-122) across hematologic malignancies and solid tumors. Sponsored by pharmaceutical organizations and academic collaborators, these investigations examine single-agent safety, pharmacokinetics, and combination regimens in both patient populations and healthy volunteers. Trial recruitment statuses across this clinical portfolio include completed, active not recruiting, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05688475 ACTIVE_NOT_RECRUITING
Non-Hodgkin Lymphoma
Bristol-Myers Squibb
2023-04-11 PHASE1
NCT02031419 TERMINATED
Lymphoma, Large B-Cell, Diffuse
Celgene
2013-12-18 PHASE1
NCT01421524 COMPLETED
Multiple Myeloma; Lymphoma, Large B-Cell, Diffuse; Pleiotropic Pathway Modifier; Glioblastoma; Lymphoma; Primary Central Nervous System Lymphoma
Celgene
2011-09-12 PHASE1
NCT02509039 TERMINATED
Lymphoma, Non-Hodgkin
Celgene
2015-09-02 PHASE1
NCT05688475 Active not recruiting
Non-Hodgkin Lymphoma
Bristol-Myers Squibb
2023-04-11 Phase 1
NCT03310619 COMPLETED
Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular
Celgene
2017-12-20 PHASE1; PHASE2
NCT03834623 COMPLETED
Melanoma
H. Lee Moffitt Cancer Center and Research Institute
2019-05-14 PHASE2
NCT02406742 COMPLETED
Leukemia, Lymphocytic, Chronic, B-Cell
Celgene
2015-07-27 PHASE1; PHASE2
NCT02859324 COMPLETED
Carcinoma, Hepatocellular
Celgene
2016-09-20 PHASE1; PHASE2
NCT03283202 COMPLETED
Diffuse B-Cell Lymphoma
Celgene
2017-10-04 PHASE1
NCT02417285 COMPLETED
Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
Celgene
2015-05-22 PHASE1
NCT03834623 Completed
Melanoma
H. Lee Moffitt Cancer Center and Research Institute|Bristol-Myers Squibb|Celgene Corporation
2019-05-14 Phase 2
NCT03340662 COMPLETED
Healthy Volunteer
Celgene
2017-11-09 PHASE1
NCT03097016 COMPLETED
Renal Insufficiency
Celgene
2017-03-30 PHASE1
NCT02323906 TERMINATED
Carcinoma, Hepatocellular
Celgene
2015-01-16 PHASE1
NCT02406742 Completed
Leukemia Lymphocytic Chronic B-Cell
Celgene
2015-07-27 Phase 1|Phase 2
NCT02234999 COMPLETED
Healthy Volunteers
Celgene
2014-09-23 PHASE1
NCT02234999 Completed
Healthy Volunteers
Celgene
2014-09-23 Phase 1
NCT02049528 COMPLETED
Clinical Pharmacology, Healthy Male Volunteer Study
Celgene
2014-01-16 PHASE1
NCT01421524 Completed
Multiple Myeloma|Lymphoma Large B-Cell Diffuse|Pleiotropic Pathway Modifier|Glioblastoma|Lymphoma|Primary Central Nervous System Lymphoma
Celgene
2011-09-12 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-11)

Check the Avadomide (CC-122) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avadomide selectively binds to cereblon (CRBN), the substrate receptor of the CRL4^CRBN E3 ubiquitin ligase complex, thereby promoting targeted ubiquitination and proteasomal degradation of substrate proteins to impair downstream oncogenic signaling pathways. This targeted protein degradation induces tumor cell apoptosis and enhances immunomodulatory cellular responses, providing antitumor activity in clinical trial settings such as diffuse large B-cell lymphoma, multiple myeloma, and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.