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

ConditionPrimary Plasma Cell Leukemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorHellenic Society of Hematology

About this trial

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 criteria

Qualifiers

Age between 18 and 80 years (inclusive) at the time of signing the informed consent.

Documented presence of ≥5% PBPCs and/or absolute number ≥0.5 × 103/μL, assessed either morphologically in the peripheral blood (PB) smear or by flow cytometry, and confirmation of plasma cell clonality by flow cytometry

Clonal BMPCs ≥10% or biopsy-proven bony or extramedullary plasmacytoma

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)

Disqualifiers

None

Trial design

Treatments tested in this trial

Daratumumab (Subcutaneously)

Treatment groups

43 Participants

are divided into 1 treatment group

Sponsors and collaborators

Hellenic Society of Hematology

Lead sponsor

Source ClinicalTrials.gov