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
- Conditions
- Primary Plasma Cell Leukemia
- Interventions
- Registration Number
- NCT06636552
- Lead Sponsor
- Hellenic Society of Hematology
- Brief 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.
- Detailed Description
This is an investigator-initiated, prospective, multicenter, phase II, open-label, single-arm, non-randomized, single-stage clinical trial.
The study comprises the following phases:
A 28-day screening phase An induction phase which includes six 21-day induction treatment cycles of alternating D-PAD and D-CVD (starting with D-PAD) Note: Based on the post-induction treatment disease evaluation, transplant-eligible subjects who have achieved ≥SD and PBPC ≤2% will undergo ASCT whereas those with SD or PBPC 2% will discontinue study treatment. Accordingly, transplant-eligible subjects who have achieved ≥PR will receive 2 additional D-CVD cycles whereas those with \<PR will discontinue study treatment.
ASCT (single or tandem) (applicable for transplant-eligible patients) 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 \[Cycle 8\]) An End of Treatment (EOT) visit: 30 days (±7 days) after the last dose of all components of the study treatment have been discontinued
A Post-Treatment Follow-Up (PTFU) phase which will begin once a subject permanently discontinues study treatment. In particular:
All subjects who complete or discontinue study treatment without disease progression (PD), will return to the site every 12 weeks (±2 weeks) for disease evaluation (or sooner at Investigator's discretion if there are concerns for progression/relapse) and other follow-up assessments until the earliest of confirmed PD, start of subsequent therapy for PCL, death, or the end of study (EOS) definition is met.
After confirmed PD or the start of a new anticancer treatment for PCL, subjects will return to the site or be contacted by telephone every 16 weeks (±2 weeks) for collection of follow-up information (i.e., other malignancies, next-line therapy, and survival, as applicable) until death, withdrawal of consent for study participation, or the EOS definition is met, whichever occurs first.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm Daratumumab (Subcutaneously) * 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 Measures
Name Time Method 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. Approximately 28 months (including induction/consolidation/maintenance phase and excluding transplantation) [168 days induction/consolidation plus 672 days maintenance]. 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 Outcome Measures
Name Time Method
Trial Locations
- 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
🇬🇷Alexandroupolis, 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