RecruitingPhase 2NCT06636552

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 L

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


Sponsor

Hellenic Society of Hematology

Enrollment

43 participants

Start Date

Nov 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to evaluate the efficacy of the alternating D-PAD/D-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment for primary plasma cell leukemia (pPCL), a rare and aggressive blood cancer. The treatment combines two types of cancer drugs — bortezomib-based regimens and daratumumab — used in an alternating schedule, followed by daratumumab as maintenance therapy. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with primary plasma cell leukemia (a rare, aggressive form of multiple myeloma) - Your disease meets specific measurable criteria for blood and bone marrow involvement - Your heart, liver, and kidney function meet the required thresholds - You are willing to use contraception if applicable **You may NOT be eligible if...** - You have received any prior treatment for this cancer - You have serious liver failure, uncontrolled infections, or active hepatitis - You have had a recent heart attack, significant heart disease, or serious clotting problems - You are pregnant or breastfeeding - You are allergic to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab (Subcutaneously)

D-PAD (21-Day Cycles 1, 3 and 5): 1,800 mg (QW) SC on days 1, 8, and 15 (for Cycles 1 and 3) 1,800 mg (Q3W) SC on day 1 (for Cycle 5) D-CVD (21-Day Cycles 2, 4, 6, 7 and 8): 1,800 mg (QW) SC on days 1, 8, and 15 (for Cycle 2) 1,800 mg (Q3W) SC on day 1 (for Cycles 4, 6, 7 and 8) Daratumumab monotherapy (28-Day Cycles 9 to 32): 1,800 mg (Q4W) SC on day 1


Locations(7)

1st Propaedeutic Department, "Laiko" General Hospital of Athens

Athens, Attica, Greece

Hematology Clinic, General Hospital of Athens "Evanggelismos"

Athens, Attica, Greece

Hematology Department "Alexandra" General Hospital of Athens

Athens, Attica, Greece

Hematology Department, University General Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Hematology Department, Regional General Hospital for Cancer Treatment "Metaxa" of Piraeus

Piraeus, Greece

Hematology Department, General Hospital of Thessaloniki "Papanikolaou"

Thessaloniki, Greece

Hematology Department, Theageneion Cancer Hospital

Thessaloniki, Greece

View Full Details on ClinicalTrials.gov

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NCT06636552


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