A phase 1/2, dose and schedule evaluation study to investigate the safety and clinical activity of Belantamab Mafodotin administered in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma translplant ineligible.

Hellenic Society of Hematology (EAE)0 sites66 target enrollmentJanuary 29, 2021

DrugsRevlimid 25mg Revlimid 20mg Revlimid 15mg Revlimid 10mg Revlimid 5mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Hellenic Society of Hematology (EAE)
Enrollment: 66
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 29, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Hellenic Society of Hematology (EAE)

Eligibility Criteria

Inclusion Criteria

•1\.Participant aged 18 years or older
•2\.Monoclonal plasma cells in the bone marrow \=10% or presence of a biopsy proven plasmacytoma and documented MM satisfying at least 1 of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria:
•CRAB criteria:
•v.Hypercalcemia: serum calcium\>0\.25 mmol/L (\>1 mg/dL) higher than ULN or \>2\.75 mmol/L(\>11 mg/dL)
•vi.Renal insufficiency: creatinine clearance\<40mL/min or serum creatinine\>177 µmol/L(\>2 mg/dL)
•vii.Anemia: hemoglobin\>2 g/dL below the lower limit of normal or hemoglobin \<10 g/dL
•viii.Bone lesions: 1 or more osteolytic lesions on skeletal radiography, CT, or PET\-CT
•Any 1 or more of the following biomarkers of malignancy:
•a.Clonal bone marrow plasma cell percentage \=60%
•b.Involved: uninvolved serum FLC ratio \=100

Exclusion Criteria

•1\.Prior systemic therapy for MM, or smoldering MM (SMM).
•2\.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute , Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5\.
•3\.Major surgery within 4 weeks before the first dose of study drug.
•4\.Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect the participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided that they fulfil the other inclusion criteria.
•5\.Any serious and/or unstable pre\-existing medical or, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance with the study procedures.
•6\.Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
•7\.Current active liver or biliary disease (except for Gilbert’s syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the Investigator’s assessment).
•8\.Participants with previous or concurrent malignancies other than multiple myeloma. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
•9\.Evidence of cardiovascular risk including any of the following:
•Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities, second degree (Mobitz Type II) or third degree atrioventricular (AV) block.