multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: NEULASTA*6MG 1PEN 0,6ML SC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegfilgrastim
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients candidates to autotransplant and responsive to debulking therapy Age=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diagnosis of smoldering myeloma or MGUS or Waldenstrom?s disease; Primary refractory patients to first-line therapy. Patients must have obtained at least a minimal response to first line therapy. HBV, HIV, HCV positive serology; Spleen size of ≥12 cm in the greatest dimension by splenic ultrasonography; Patients with prior history of pelvic radiotherapy for myeloma treatment; History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric disturbances; Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Appendix D, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of mobilisation of PBSC followed by a single dose of 6 mg Pegfilgrastim in multiple myeloma patients eligible to autologous transplant;Secondary Objective: To evaluate the toxicity profile of Pegfilgrastim during PBSC mobilisation;Primary end point(s): The number and proportion of patients from whom ≥ 2 x 106 CD34+ cells/kg are harvested | — |
Countries
Italy
Outcome results
None listed