An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination with DaratUMumab followed by Maintenance with Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study Group. The EUMELEIA Study - The EUMELEIA ” Study

Hellenic Society of Haematology (HSH)0 sites43 target enrollmentJune 22, 2021

ConditionsPrimary plasma cell leukemia MedDRA version: 20.0Level: LLTClassification code 10035223Term: Plasma cell leukemiaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsDarzalex 1.800mg Velcade 3,5mg ENDOXAN C. TAB 50mg/TAB DEXATON oral sol. 2mg/5ml BT X 1 BOTTLE X 150 ml ADRIBLASTINA 10mg/5ml ADRIBLASTINA 50mg/25ml

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Primary plasma cell leukemia
Sponsor: Hellenic Society of Haematology (HSH)
Enrollment: 43
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 22, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Hellenic Society of Haematology (HSH)

Eligibility Criteria

Inclusion Criteria

•1\.Female or male patients of any race or ethnicity, aged between 18 and 80 years (inclusive) at the time of signing the ICF.
•2\.Patients newly diagnosed with documented pPCL as defined by the current IMWG criteria for PCL and MM \[5,34]:
•2\.1 Documented presence of \=5% PBPCs and/or absolute number \=0\.5 × 103/µL (by flow cytometry)
•2\.2 Clonal BMPCs \=10% or biopsy\-proven bony or extramedullary plasmacytoma (EMP)
•2\.3 At least one of the following myeloma defining events (CRAB or malignancy biomarkers criteria
•\- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following):
•a) Hypercalcemia: serum calcium \>0\.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal (ULN) or \>2\.75 mmol/L (\>11 mg/dL)
•b) Renal insufficiency: Creatinine clearance (CrCl) \<40 mL/min (measured or estimated by validated equations) or serum creatinine \>177 µmol/L (\>2 mg/dL)
•c) Anemia: hemoglobin value of \>20 g/L below the lower limit of normal (LLN), or a hemoglobin value \<100 g/L
•d) Bone lesions: One or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)\-CT.

Exclusion Criteria

•1\. Patients with secondary PCL.
•2\. Prior or concurrent invasive malignancy (other than PCL) within 5 years of date of study treatment initiation except for the following:
•2\.1 Malignancy treated with curative intent and with no known active disease present for \=3 years before study treatment initiation.
•2\.2 Adequately treated non\-melanoma skin cancer, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer (T1a or T1b) or other non\-invasive lesion that, as per Investigator’s judgement, is considered cured with minimal risk of recurrence over the next 3 years.
•3\. Radiation therapy within 14 days before study treatment initiation.
•4\. Plasmapheresis within 28 days before study treatment initiation.
•5\. Exhibiting clinical signs of meningeal or central nervous system involvement by PCL.
•6\. Patients with peripheral neuropathy or neuropathic pain Grade 2 or higher
•7\. Concurrent systemic amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and/or skin changes), active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease, and any other medical condition/disease that is likely to interfere with the study procedures or results, or that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•8\. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second \[FEV1] \<50% of predicted normal.