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

Sponsor
Hellenic Society of Hematology
Study ID
NCT06636552
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Plasma Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab (Subcutaneously) — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 19, 2021
Status verified
Oct 2024
Primary completion
Jan 5, 2029
Completion
Jan 5, 2029

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single-arm
    * A consolidation phase which includes two 21-day consolidation cycles of D-CVD * A maintenance phase which includes twenty-four 28-day cycles of daratumumab monotherapy (applicable for subjects who have achieved ≥PR at the end of consolidation phase \[Cycle 8\])

Primary Outcome Measure

Εfficacy 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. [ Time Frame: Approximately 28 months (including induction/consolidation/maintenance phase and excluding transplantation) [168 days induction/consolidation plus 672 days maintenance]. ]

Central Contacts