Ocular Monitoring
This term is used to describe the potential or actual side effects associated with BLENREP, particularly those affecting the cornea
What are ocular toxicities?
This was the primary endpoint measured in the DREAMM-7 and DREAMM-8 clinical trials evaluating BLENREP for multiple myeloma treatment.
What is progression-free survival (PFS)?
These four key features—hyperCalcemia, Renal failure, Anemia, and Bone lesions—are used to diagnose and monitor multiple myeloma
What are CRAB features?
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What is a Medical Information Request Form (MIRF)?
Who is James Green?
These assessments are included in the baseline and pre-infusion eye exam for patients receiving BLENREP to monitor for ocular toxicity.
What is a slit lamp exam and best corrected visual acuity(BCVA)?
This antibody-drug conjugate targets BCMA on plasma cells, delivering a cytotoxic agent that induces cell death in multiple myeloma.
What is the mechanism of action of belantamab mafodotin?
Renal impairment in multiple myeloma is often caused by the accumulation of this abnormal protein produced by malignant plasma cells
What is M protein (or monoclonal protein)?
Could also accept "light chains" (especially Bence Jones proteins), which are a type of M protein that directly damage the kidneys
When an Associate or Associated Person receives written safety information, this is the maximum number of business days they must report to SPVG, along with all related documentation such as emails, medical records, and notes.
What is one (1) business day?
The number of Eyecare Educator Specialists currently supporting all regions.
What is 38?
These microscopic deposits in the corneal epithelium resemble cysts and are a known ocular side effect of BLENREP.
What are microcyst-like epithelial changes (MECs)?
Adult patients with relapsed or refractory multiple myeloma (RRMM) who received more than one prior line of therapy and had disease progression during or after the most recent therapy
What is DREAMM-7 key inclusion criteria?
This type of cancer arises from abnormal plasma cells in the bone marrow
What is multiple myeloma?
This term describes any unfavorable and unintended sign (including abnormal lab findings), symptom, or disease that occurs after using a medicinal or investigational product, regardless of whether it's considered related.
What is an Adverse Event (AE)?
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What is the blank area on the marketing material?
These noninflammatory changes to the outer layer of the cornea can cause blurred vision and are commonly associated with BLENREP treatment.
What is keratopathy?
Phase 3, randomized, open-label, global trail that evaluated the efficacy and safety of belantamab mafodotin with pomalidomide and dexamethasone compared to pomalidomide and bortezomib and dexamethasone in patients with RRMM previously treated with lenalidomide.
What is DREAMM-8?
This benign plasma cell disorder is considered a precursor state to multiple myeloma, characterized by the presence of monoclonal protein without symptoms or organ damage.
What is MGUS (Monoclonal Gammopathy of Undetermined Significance)?
If you witness or suspect a violation of company policy or the law, this is the person or department you should contact first.
What is the Compliance Department? GSK_Compliance@syneoshealth.com ? Frank Virgili?
This term describes the process by which all blood cells, including red cells, white cells, and platelets, are formed in the bone marrow.
What is hematopoiesis?
This describes an ocular event involving moderate superficial keratopathy and a decline in best corrected visual acuity by 2-3 lines from baseline
What is a Grade 2 Moderate Ocular Adverse Event?
In the DREAMM-7 and DREAMM-8 trials, these were the key secondary endpoints alongside progression-free survival to evaluate BLENREP’s effectiveness and safety in multiple myeloma.
What are overall survival (OS), duration of response (DOR), and response to treatment?
This plasma cell disorder is asymptomatic and has no CRAB features but carries a risk of progressing to active multiple myeloma.
What is smoldering multiple myeloma?
To ensure credibility and trust, all messaging and content must adhere to this principle, meaning it is presented without bias and considers all relevant viewpoints.
What is fair and balanced?
The 5 most commonly reported ocular events with treatment with BLENREP.
What is blurred vision, dry eye, photophobia, eye irritation, and foreign body sensation?