^
    6d
    ISABELA: Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=50, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2025 --> Dec 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf)
    1m
    Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=5, Active, not recruiting, OHSU Knight Cancer Institute | Trial primary completion date: Apr 2026 --> Oct 2026
    Trial primary completion date
    |
    carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc)
    1m
    The real-world safety profile and potential mechanism of isatuximab: Integration of pharmacovigilance and transcriptomic analysis. (PubMed, Medicine (Baltimore))
    By synergizing real-world pharmacovigilance with transcriptomic data, this study delineates novel clinical AE signals and mechanistic insights linking CD38-driven immunometabolic dysregulation to isatuximab toxicity. These findings underscore the imperative for vigilant monitoring and tailored therapeutic strategies to mitigate risks of immune dysfunction, informing both clinical practice and future biomarker-driven interventions.
    Journal • Adverse events • Real-world evidence • IO biomarker
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    IFNG (Interferon, gamma)
    |
    Sarclisa (isatuximab-irfc)
    2ms
    Inflammatory Biomarkers for Thrombotic Risk Assessment in Multiple Myeloma Patients on IMiD/aCD38-Based Regimens: Insights from a Prospective Observational Study. (PubMed, Biomolecules)
    Treatment regimens comprised lenalidomide (n = 36) or thalidomide (n = 15) with daratumumab, and pomalidomide (n = 2) with isatuximab. Most patients (n = 38) received frontline therapy, and all were given thromboprophylaxis according to guidelines, mainly aspirin (73%)...Given the limited number of patients and thrombotic events, and the cytokine data available for only two VTE cases, these associations should be regarded as exploratory and interpreted with caution. Overall, these exploratory findings warrant validation in larger, independent cohorts and may help generate hypotheses on how inflammatory signatures influence thrombotic risk and prophylaxis efficacy in MM patients receiving IMiD/anti-CD38-based regimens.
    Observational data • Journal • IO biomarker
    |
    B2M (Beta-2-microglobulin) • CSF1 (Colony stimulating factor 1)
    |
    lenalidomide • Darzalex (daratumumab) • pomalidomide • thalidomide • Sarclisa (isatuximab-irfc)
    2ms
    Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients (clinicaltrials.gov)
    P2, N=61, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial primary completion date
    |
    lenalidomide • Sarclisa (isatuximab-irfc)
    2ms
    DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P2, N=208, Active, not recruiting, GlaxoSmithKline | Trial completion date: Feb 2029 --> Mar 2027 | Trial primary completion date: Feb 2029 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    3ms
    Non-Competitive Binding of Isatuximab and Daratumumab to CD38: Implications for Targeted Therapy in Multiple Myeloma. (PubMed, Pharmaceutics)
    The effects of IMiDs (pomalidomide, lenalidomide) on CD38 expression and isatuximab-induced apoptosis, either alone or in combination with IMiDs, were also examined. Additionally, both antibodies effectively inhibited MM cell migration and significantly reduced cell adhesion. Their non-competitive binding and shared impact on cell dynamics suggest opportunities for optimizing treatment strategies through combinatorial or sequential approaches in MM therapy.
    Journal • IO biomarker
    |
    CXCR4 (Chemokine (C-X-C motif) receptor 4) • ITGA4 (Integrin, alpha 4)
    |
    lenalidomide • Darzalex (daratumumab) • pomalidomide • Sarclisa (isatuximab-irfc)
    3ms
    Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, GlaxoSmithKline
    New P1/2 trial
    |
    Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf)
    3ms
    UltraFrailMM: Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Recruiting, University of Utah | Not yet recruiting --> Recruiting
    Enrollment open
    |
    lenalidomide • Sarclisa (isatuximab-irfc)
    4ms
    Validation of novel low-dose CT methods for quantifying bone marrow in the appendicular skeleton of patients with multiple myeloma: initial results from the [18F]FDG PET/CT sub-study of the Phase 3 GMMG-HD7 Trial. (PubMed, Eur J Nucl Med Mol Imaging)
    Novel CT-based quantification approaches for assessing BM involvement in the appendicular skeleton correlate with key clinical and PET parameters in MM. As low-dose, standardized techniques, they show promise for inclusion in MM imaging protocols, potentially enhancing assessment of disease extent and treatment response.
    P3 data • Journal
    |
    B2M (Beta-2-microglobulin)
    |
    lenalidomide • bortezomib • Sarclisa (isatuximab-irfc)
    4ms
    Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation (clinicaltrials.gov)
    P1/2, N=23, Terminated, Sanofi | Phase classification: P1b/2 --> P1/2
    Phase classification
    |
    Sarclisa (isatuximab-irfc)
    4ms
    S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis (clinicaltrials.gov)
    P2, N=43, Completed, SWOG Cancer Research Network | Active, not recruiting --> Completed
    Trial completion
    |
    NPPB (Natriuretic Peptide B)
    |
    Sarclisa (isatuximab-irfc)