Primary Plasma Cell Leukemia MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration number: 25-
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Voluntarily written informed consent released before any study-related procedure which is not part of normal medical care is performed, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. ? Female subjects are either post-menopausal or surgically sterilized or willing to use 2 simultaneous methods of contraception (ie intrauterine devices [IUD] or hormonal contraceptives and one barrier method as latex condoms, diaphragms, cervical caps) throughout the study and for at least 28 days after discontinuation of lenalidomide. ? Male patients must agree to use a latex condom during sexual contact with females of childbearing potential throughout the study and for at least 28 days following discontinuation of lenalidomide; they also must agree to abstain from donating blood, semen, or sperm for the whole duration of the study ? Patients fulfilling the IMWG diagnostic criteria of PPCL at diagnosis (6) ? Patients > 18 years of age ? ECOG Performance Status of 0,1 or 2 ? Patients with a life expectancy of at least 12 weeks. ? Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. ? Female subjects either pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women. ? Patients have received other investigational drugs with 14 days before enrollment ? Serious medical or psychiatric illness likely to interfere with participation in this clinical study. ? Patients with renal dysfunction secondary to PPCL may be enrolled at the discretion of the principal investigator. However, patients on hemodialysis or peritoneal dialysis are not eligible. ? Patients with a total bilirubin greater than 2.0 mg/dL and SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible. ? Patients with active infections are ineligible. ? Patients who are HIV positive are ineligible. ? ? Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous CSF tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. ? Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible. ? Patients with an ECOG performance status of > 2 are ineligible, however ? Patients with an ECOG performance status of 3, secondary to primary disease, may be enrolled at the discretion of the institutional investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the antitumor activity of the lenalidomide/dexamethasone combination, as first line therapy in patients with PPCL.;Secondary Objective: To evaluate the safety of the lenalidomide/dexamethasone combination in patients with untreated PPCL.;Primary end point(s): The primary endpoint of the study is the response rate according to International Uniform Criteria;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety of the lenalidomide/dexamethasone combination in patients with untreated PPCL.;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactFondazione Neoplasie Sangue Onlus
FO.NE.SA
Outcome results
None listed