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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518263-35-00

Acronym

54767414LEU2002

Enrollment

Registered

2024-12-09

Start date

2021-11-23

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary plasma cell leukemia

Brief summary

PFS: Duration from the date of induction treatment initiation to the date of first documented evidence of progressive disease (PD) (assessed by the IMWG criteria or death, whichever occurs earlier.

Detailed description

Proportions of patients achieving PR or better, VGPR or better, and sCR or CR (as determined by the IMWG criteria)

Interventions

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGDARZALEX 1800 mg solution for injection

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGDEXAMETHASONE SODIUM PHOSPHATE

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS: Duration from the date of induction treatment initiation to the date of first documented evidence of progressive disease (PD) (assessed by the IMWG criteria or death, whichever occurs earlier.	—

Secondary

Measure	Time frame
Proportions of patients achieving PR or better, VGPR or better, and sCR or CR (as determined by the IMWG criteria)	—

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026