A single arm phase 2 study on the efficacy of Pegfilgrastim (Neulasta) after DCEP chemotherapy: a feasibility study in multiple myeloma patients eligible for autologous transplant. - ND
- Conditions
- multiple myelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2008-000103-29-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients candidates to autotransplant and responsive to debulking therapy
Age< 70 years; Absence of severe associated pulmonary, cardiac, metabolic, or concomitant neoplasia. written informed consent, ...
Are the trial subjects under 18? no
Number of subjects for this age range:
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method