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Lenalidomide, Dexamethasone, PBSCT
Lenalidomide, Dexamethasone, PBSCT is a Immunomodulatory agent + corticosteroid + stem cell transplantation Small molecule drug developed by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed or relapsed/refractory). Also known as: Revlimid.
Lenalidomide enhances immune cell activity and promotes apoptosis of myeloma cells, while dexamethasone provides anti-inflammatory and anti-tumor effects, followed by peripheral blood stem cell transplantation to restore bone marrow function.
Lenalidomide enhances immune cell activity and promotes apoptosis of myeloma cells, while dexamethasone provides anti-inflammatory and anti-tumor effects, followed by peripheral blood stem cell transplantation to restore bone marrow function. Used for Multiple myeloma (newly diagnosed or relapsed/refractory).
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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 | Lenalidomide, Dexamethasone, PBSCT |
|---|---|
| Also known as | Revlimid |
| Sponsor | Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH |
| Drug class | Immunomodulatory agent + corticosteroid + stem cell transplantation |
| Target | Cereblon (CRBN), TNF-α, IL-2, glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lenalidomide is an immunomodulatory agent that activates T cells and natural killer cells while inducing direct cytotoxicity in multiple myeloma cells. Dexamethasone is a corticosteroid that enhances lenalidomide's anti-myeloma effects and provides additional immunosuppression. PBSCT (peripheral blood stem cell transplantation) is a supportive procedure that allows for high-dose chemotherapy and restoration of hematopoietic function.
Approved indications
- Multiple myeloma (newly diagnosed or relapsed/refractory)
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Infection
- Peripheral neuropathy
- Hyperglycemia
- Insomnia
- Fatigue
Key clinical trials
- Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (PHASE3)
- Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06) (PHASE2)
- Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma (PHASE3)
- Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma (PHASE2)
- UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (PHASE2)
- Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma (PHASE4)
- Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma (PHASE1)
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:
- Lenalidomide, Dexamethasone, PBSCT CI brief — competitive landscape report
- Lenalidomide, Dexamethasone, PBSCT updates RSS · CI watch RSS
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH portfolio CI
Frequently asked questions about Lenalidomide, Dexamethasone, PBSCT
What is Lenalidomide, Dexamethasone, PBSCT?
How does Lenalidomide, Dexamethasone, PBSCT work?
What is Lenalidomide, Dexamethasone, PBSCT used for?
Who makes Lenalidomide, Dexamethasone, PBSCT?
Is Lenalidomide, Dexamethasone, PBSCT also known as anything else?
What drug class is Lenalidomide, Dexamethasone, PBSCT in?
What development phase is Lenalidomide, Dexamethasone, PBSCT in?
What are the side effects of Lenalidomide, Dexamethasone, PBSCT?
What does Lenalidomide, Dexamethasone, PBSCT target?
Related
- Drug class: All Immunomodulatory agent + corticosteroid + stem cell transplantation drugs
- Target: All drugs targeting Cereblon (CRBN), TNF-α, IL-2, glucocorticoid receptor
- Manufacturer: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed or relapsed/refractory)
- Also known as: Revlimid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing