NCT06636552View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 19, 2021

Primary Completion Date

January 5, 2029

Study Completion Date

January 5, 2029

Conditions
Primary Plasma Cell Leukemia
Interventions
DRUG

Daratumumab (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"

Trial Locations (7)

Unknown

RECRUITING

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

RECRUITING

Hematology Clinic, General Hospital of Athens "Evanggelismos", Athens

RECRUITING

Hematology Department "Alexandra" General Hospital of Athens, Athens

RECRUITING

Hematology Department, University General Hospital of Alexandroupolis, Alexandroupoli

RECRUITING

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

RECRUITING

Hematology Department, General Hospital of Thessaloniki "Papanikolaou", Thessaloniki

RECRUITING

Hematology Department, Theageneion Cancer Hospital, Thessaloniki

All Listed Sponsors
lead

Hellenic Society of Hematology

OTHER