A PHASE 1/2, DOSE AND SCHEDULE EVALUATION STUDY TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN ADMINISTERED IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE WITH OR WITHOUT DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA PREVIOUSLY TREATED WITH ONE TO THREE LINES OF THERAPY WHO ARE LENALIDOMIDE REFRACTORY

Hellenic Society of Hematology (EAE)0 sites60 target enrollmentAugust 2, 2022

Overview

No summary available.

Registry

who.int

Start Date

August 2, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Hellenic Society of Hematology (EAE)

•1\. Participant must be \=18 years.
•2\. Documented diagnosis of MM as per IMWG criteria.
•3\. Must have at least ONE aspect of measurable disease, defined as 1 of following:
•a. Urine M\-protein excretion \=200 mg/24 hrs (\=0\.2 g/24 hrs), or
•b. Serum M\-protein concentration \=0\.5 g/dL (\=5\.0 g/L), or
•c. Serum FLC assay: involved FLC level \=10 mg/dL (\=100 mg/L) and an abnormal serum FLC ratio (\<0\.26 or \>1\.65\).
•4\. ECOG performance status of 0–2\.
•5\. Adequate organ system function defined by following assessments.
•Hematologic
•a. Absolute neutrophil count \=1\.5 X 10^9/L; granulocyte colony stimulating factor use within the past 14 days is NOT permitted.

•1\. Peripheral neuropathy or neuropathic pain \=Grade 2, per NCI CTCAEs V5\.
•2\. Major surgery within 4 weeks before 1st dose.
•NOTE: must be clinically stable following major surgery.
•NOTE: major surgery shall be defined by Investigator.
•3\. Presence of active renal condition. Participants with isolated proteinuria resulting from MM are eligible if they fulfil other inclusion criteria.
•4\. Any serious and/or unstable pre\-existing medical or psychiatric disorder, or other conditions that may interfere with participant’s safety, obtaining informed consent or complying to procedures.
•5\. Active mucosal or internal bleeding uncontrolled by local therapy and unexplained by reversible coagulopathy.
•6\. Current active unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis (except for Gilbert’s syndrome or asymptomatic gallstones; otherwise, stable non\-cirrhotic chronic liver disease; or hepatobiliary involvement of malignancy as per Investigator).
•7\. Participants with previous or concurrent malignancies other than MM are excluded, except surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for \=2 years. The participant must not receive therapy, other than hormonal.
•NOTE: Participants with cured non\-melanoma skin cancer are allowed without restriction.