Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients.
Recruiting
- Conditions
- Multiple myeloma (Kahler's disease)
- Registration Number
- NL-OMON25322
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
• Patients with diagnosis of symptomatic pPCL (see appendix A)
• Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 5 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
Exclusion Criteria
• Any current CNS involvement with disease refractory to intrathecal chemotherapy.
• Female patients who are pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Progression-free survival (PFS, i.e. time from registration until progression or death, whichever comes first)
- Secondary Outcome Measures
Name Time Method • Overall response rate (at least PR) after the different phases of treatment<br /><br>• (s)CR + VGPR ((stringent) complete and very good partial response) after the different phases of treatment<br /><br>• Overall survival, defined as time from registration until death from any cause. Patients still alive at the date of last contact, will be censored<br /><br>• Toxicity and tolerability of the different phases of treatment<br /><br>• Explore the value of prognostic factors including FISH abnormalities, β2-microgloublin, LDH, MRD-negativity, pPCL gene expression profiles and sequencing results on the overall response, overall survival and progression–free survival<br /><br>• Frequency of second primary malignancies<br>