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CC-5013 plus dexamethasone
CC-5013 plus dexamethasone is a Immunomodulatory agent plus corticosteroid Small molecule drug developed by Celgene. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory). Also known as: Revlimid, lenalidomide.
CC-5013 (lenalidomide) is an immunomodulatory agent that enhances T-cell proliferation and cytokine production while dexamethasone provides corticosteroid-mediated anti-inflammatory and anti-proliferative effects.
CC-5013 plus dexamethasone is a treatment combination used to study multiple myeloma, a type of blood cancer. CC-5013 is a small molecule modality, specifically a combination of the small molecule CC-5013 and the corticosteroid dexamethasone.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | CC-5013 plus dexamethasone |
|---|---|
| Also known as | Revlimid, lenalidomide |
| Sponsor | Celgene |
| Drug class | Immunomodulatory agent plus corticosteroid |
| Target | Cereblon (CRBN); glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lenalidomide binds to cereblon (CRBN), a component of an E3 ubiquitin ligase complex, leading to selective degradation of IKZF1 and IKZF3 proteins and enhanced immune cell activation. Dexamethasone, a glucocorticoid, suppresses inflammatory cytokines and enhances the anti-myeloma effects of lenalidomide. Together, this combination targets multiple pathways in malignant plasma cells.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Infection
- Peripheral neuropathy
- Hyperglycemia
- Insomnia
- Constipation
Key clinical trials
- Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (PHASE3)
- Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (PHASE2)
- A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
- Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma (PHASE3)
- A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant (PHASE3)
- A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (PHASE2, PHASE3)
- A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CC-5013 plus dexamethasone CI brief — competitive landscape report
- CC-5013 plus dexamethasone updates RSS · CI watch RSS
- Celgene portfolio CI
Frequently asked questions about CC-5013 plus dexamethasone
What is CC-5013 plus dexamethasone?
How does CC-5013 plus dexamethasone work?
What is CC-5013 plus dexamethasone used for?
Who makes CC-5013 plus dexamethasone?
Is CC-5013 plus dexamethasone also known as anything else?
What drug class is CC-5013 plus dexamethasone in?
What development phase is CC-5013 plus dexamethasone in?
What are the side effects of CC-5013 plus dexamethasone?
What does CC-5013 plus dexamethasone target?
Related
- Drug class: All Immunomodulatory agent plus corticosteroid drugs
- Target: All drugs targeting Cereblon (CRBN); glucocorticoid receptor
- Manufacturer: Celgene — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed and relapsed/refractory)
- Also known as: Revlimid, lenalidomide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing