Last reviewed 2026-04-23 · How we verify

Lenalidomide-Dexamethasone-DLI

Ciusss de L'Est de l'Île de Montréal · Phase 2 active Small molecule

Lenalidomide-Dexamethasone-DLI is a Immunomodulatory drug and corticosteroid Small molecule drug developed by Ciusss de L'Est de l'Île de Montréal. It is currently in Phase 2 development for Multiple myeloma, Mantle cell lymphoma, Myelodysplastic syndromes.

Lenalidomide is an immunomodulatory drug that targets the ubiquitin-proteasome pathway, and Dexamethasone is a corticosteroid that modulates the immune response. DLI (Donor Lymphocyte Infusion) is a form of immunotherapy that involves infusing donor lymphocytes to treat hematologic malignancies.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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-DLI
Sponsor	Ciusss de L'Est de l'Île de Montréal
Drug class	Immunomodulatory drug and corticosteroid
Target	Ubiquitin-proteasome pathway
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Lenalidomide works by inhibiting the proteasome, which leads to the accumulation of ubiquitinated proteins and the activation of immune cells. Dexamethasone has anti-inflammatory and immunosuppressive effects, which can help to reduce the risk of graft-versus-host disease. DLI is used to treat relapsed or refractory hematologic malignancies after allogeneic hematopoietic stem cell transplantation.

Approved indications

Multiple myeloma
Mantle cell lymphoma
Myelodysplastic syndromes

Common side effects

Neutropenia
Thrombocytopenia
Anemia
Fatigue
Diarrhea
Nausea
Vomiting
Headache
Dizziness
Insomnia

Key clinical trials

Len/Dex/DLI in Relapsed Multiple Myeloma After Allogeneic Stem Cell Transplant (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:

Lenalidomide-Dexamethasone-DLI CI brief — competitive landscape report
Lenalidomide-Dexamethasone-DLI updates RSS · CI watch RSS
Ciusss de L'Est de l'Île de Montréal portfolio CI

Frequently asked questions about Lenalidomide-Dexamethasone-DLI

What is Lenalidomide-Dexamethasone-DLI?

Lenalidomide-Dexamethasone-DLI is a Immunomodulatory drug and corticosteroid drug developed by Ciusss de L'Est de l'Île de Montréal, indicated for Multiple myeloma, Mantle cell lymphoma, Myelodysplastic syndromes.

How does Lenalidomide-Dexamethasone-DLI work?

What is Lenalidomide-Dexamethasone-DLI used for?

Lenalidomide-Dexamethasone-DLI is indicated for Multiple myeloma, Mantle cell lymphoma, Myelodysplastic syndromes.

Who makes Lenalidomide-Dexamethasone-DLI?

Lenalidomide-Dexamethasone-DLI is developed by Ciusss de L'Est de l'Île de Montréal (see full Ciusss de L'Est de l'Île de Montréal pipeline at /company/ciusss-de-l-est-de-l-le-de-montr-al).

What drug class is Lenalidomide-Dexamethasone-DLI in?

Lenalidomide-Dexamethasone-DLI belongs to the Immunomodulatory drug and corticosteroid class. See all Immunomodulatory drug and corticosteroid drugs at /class/immunomodulatory-drug-and-corticosteroid.

What development phase is Lenalidomide-Dexamethasone-DLI in?

Lenalidomide-Dexamethasone-DLI is in Phase 2.

What are the side effects of Lenalidomide-Dexamethasone-DLI?

Common side effects of Lenalidomide-Dexamethasone-DLI include Neutropenia, Thrombocytopenia, Anemia, Fatigue, Diarrhea, Nausea.

What does Lenalidomide-Dexamethasone-DLI target?

Lenalidomide-Dexamethasone-DLI targets Ubiquitin-proteasome pathway and is a Immunomodulatory drug and corticosteroid.

Drug class: All Immunomodulatory drug and corticosteroid drugs
Target: All drugs targeting Ubiquitin-proteasome pathway
Manufacturer: Ciusss de L'Est de l'Île de Montréal — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Multiple myeloma
Indication: Drugs for Mantle cell lymphoma
Indication: Drugs for Myelodysplastic syndromes

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing