Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
- Conditions
- Plasma cell leukemia10035227
- Registration Number
- NL-OMON50273
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
- 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 > 10 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)
- Age >=18 years
- WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL
and not by co-morbid conditions)
- Written informed consent
- Patient capable of giving informed consent (patient is legally, physically
and mentally capable of giving consent)
- All men and women of childbearing potential should use adequate highly
effective contraception during the study. Men should be offered sperm banking
before starting treatment (if applicable).
- Negative pregnancy test at entry (if applicable)
- Patient is willing and able to adhere to the requirements of the
lenalidomide Pregnancy Prevention Program (PPP) throughout study treatment
- Any current CNS involvement with disease refractory to intrathecal
chemotherapy.
- Female patients who are pregnant or breast feeding.
- HIV positive patients
- Active malignancy other than pPCL requiring treatment, or a malignancy that
has been treated with chemotherapy currently affecting bone marrow capacity
- Patients with active, uncontrolled infections
- Severe neurological or psychiatric disease
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) -
Myocardial infarction within 6 months, unstable angina, and cardiac arrhythmias
which are not controlled by conventional treatment (including medications and
cardiac devices)
- Severe pulmonary dysfunction
- Significant hepatic dysfunction (serum bilirubin or transaminases >= 3.0 times
normal level), unless related to pPCL
- Patients with GFR < 15 ml/min
- Known history of allergy to Capsidol (a cyclodextrin derivative used to
solubilize carfilzomib)
- Hypersensitivity to the active substances or to any of the excipients of the
drug products
- Previous chemotherapy or radiotherapy except local radiotherapy in case of
local myeloma progression or corticosteroids maximum 7 days for symptom control
or stabilization(this includes dexamethasone 40 mg daily) or inthrathecal
chemotherapy in case of CNS involvement
- Systemic AL amyloidosis
- Any psychological, familial, sociological and geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression-free survival (PFS, i.e. time from registration until progression<br /><br>or death, whichever comes first)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Safety and toxicity as defined by type, frequency and severity of adverse<br /><br>events as defined by the National Cancer Institute (NCI) Common Terminology<br /><br>Criteria for Adverse Events (CTCAE), version 4<br /><br>- 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<br /><br>different phases of treatment<br /><br>- Overall survival, defined as time from registration until death from any<br /><br>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 including FISH<br /><br>abnormalities, β2-microgloublin, LDH, MRD-negativity, pPCL gene expression<br /><br>profiles and sequencing results on the overall response, overall survival and<br /><br>progression-free survival<br /><br>- Frequency of second primary malignancies</p><br>