Actively Recruiting
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
Led by Hellenic Society of Hematology · Updated on 2024-10-10
43
Participants Needed
7
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years inclusive at consent
- Newly diagnosed with primary plasma cell leukemia as per IMWG criteria
- Documented presence of at least 5% peripheral blood plasma cells or absolute count ≥0.5 x10³/µL
- Clonal bone marrow plasma cells ≥10% or biopsy-proven plasmacytoma
- At least one myeloma defining event, including organ damage or biomarkers of malignancy
- Measurable disease by protein electrophoresis with defined serum or urine M-protein levels
- Planned for high-dose therapy with or without stem cell transplantation
- No prior systemic therapy or stem cell transplant for plasma cell disorders except short corticosteroid use
- Adequate bone marrow function (hemoglobin ≥7.0 g/dL, neutrophils ≥1.0 x10⁹/L, platelets ≥50 x10⁹/L or 75 x10⁹/L depending on marrow involvement)
- Adequate liver function (AST and ALT ≤2.5 times upper limit of normal, bilirubin ≤1.5 times ULN)
- Adequate renal function (creatinine clearance ≥20 mL/min)
- ECOG performance status 0 to 3
- Females of childbearing potential must use effective birth control and have negative pregnancy tests
- Males with partners of childbearing potential must use condoms and not donate sperm during and 3 months post-treatment
- Able to understand and willing to provide informed consent
You will not qualify if you...
- Secondary plasma cell leukemia
- Invasive malignancy within past 5 years except certain treated cancers
- Radiation therapy within 14 days before treatment start
- Plasmapheresis within 28 days before treatment start
- Signs of meningeal or central nervous system involvement by PCL
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- Concurrent amyloidosis, POEMS syndrome, active infection, uncontrolled diabetes, pulmonary disease, or other conditions interfering with study
- Chronic obstructive pulmonary disease with FEV1 <50% predicted
- Moderate or severe asthma within past 2 years or uncontrolled asthma
- Known HIV infection or hepatitis B or C infection
- Significant cardiac disease including recent myocardial infarction, unstable angina, heart failure, arrhythmias, or abnormal ECG
- Use of strong CYP3A4 inducers before treatment
- Allergies or intolerance to study drugs or related compounds
- Gastrointestinal disease affecting drug absorption
- Live vaccine within 4 weeks before treatment
- Major surgery within 2 weeks before treatment or planned during study start
- Use of other anticancer treatments
- Known or suspected inability to comply with study protocol
- Pregnant or breastfeeding females or males planning to father a child during or within 3 months after treatment
- Participation in other investigational studies within 30 days or 5 half-lives prior to screening
- Contraindications to any study drugs (daratumumab, bortezomib, dexamethasone, cyclophosphamide, doxorubicin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
1st Propaedeutic Department, "Laiko" General Hospital of Athens
Athens, Attica, Greece
Actively Recruiting
2
Hematology Clinic, General Hospital of Athens "Evanggelismos"
Athens, Attica, Greece
Actively Recruiting
3
Hematology Department "Alexandra" General Hospital of Athens
Athens, Attica, Greece
Actively Recruiting
4
Hematology Department, University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Actively Recruiting
5
Hematology Department, Regional General Hospital for Cancer Treatment "Metaxa" of Piraeus
Piraeus, Greece
Actively Recruiting
6
Hematology Department, General Hospital of Thessaloniki "Papanikolaou"
Thessaloniki, Greece
Actively Recruiting
7
Hematology Department, Theageneion Cancer Hospital
Thessaloniki, Greece
Actively Recruiting
Research Team
E
Eirini Katodritou, Dr
CONTACT
M
Marina Stogianni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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