Plerixafor MM02 - Plerixafor plus G-CSF after chemotherapy for the mobilization of Peripheral Blood Stem Cells (PBSCs) in Multiple Myeloma (MM) patients undergoing Autologous Stem Cell Transplantation (ASCT)

• Conditions: multiple myeloma; MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023029-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•MM patients eligible and planned for ASCT according to Istitutional guidelines
•Age > 18 years
•Written informed consent
•Performance Status = 70% (Karnofsky) or = 2 (WHO).
•White blood cell (WBC) count = 2.5 x 109 /L
•Absolute neutrophil count (ANC) = 1.5 x 109 /L
•Platelet count = 100 x 109 /L
•Serum creatinine at time of enrollment = 2.0 mg/dL
•Aspartate aminotransferase/serum glutamnic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamnic pyruvic transaminase (ALT/SGPT), and total bilirubin at time of enrollment < 2.5 x upper limit of normal (ULN)
•Adequate cardiac, renal and pulmonary function to undergo apheresis and transplantation
•All patients must agree to use highly effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential).
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•History of any acute or chronic myelogenous leukemia
•HIV positivity; active Hepatitis B or Hepatitis C
•Intercurrent organ damage or medical problems that would interfere with therapy.
•Pregnant or nursing females.
•Concurrent uncontrolled infection.
•Previously received investigation therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase
•Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?Percentage of patients collecting = 6 x 106 CD34+ cells/Kg in three or less apheresis;Secondary Objective: ?Number of apheresis to collect = 6 x 106 CD34+ cells/Kg<br>?Evaluation of engraftment after transplantation of plerixafor-mobilized PBSCs<br>?Evaluation of immunological reconstitution after transplantation<br>?Evaluation of cellular graft content<br>?Evaluation of resources consumption and relative direct costs estimation in the management of patients with plerixafor therapy in association with G-CSF after chemotherapy<br>?Percentage of patients collecting = 4 x 106 CD34+ cells/Kg in three or less apheresis following rescue strategy (plerixafor + G-CSF), and number of apheresis required;Primary end point(s): ?Number of CD34+ cells mobilized into PB <br>?Number of PBSC collections;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?Number of days to neutrophil and platelet engraftment.<br>?Kinetic of immunological reconstitution as the number of circulating lymphocytes, CD3+ , CD4+, CD8+, CD19+ , T-reg and CD56+ cells at 30 days, 3,6,9 and 12 months after transplantation.<br>?Concentration of stem cell and lymphocyte subsets into leukaphereses. <br>?Type and quantity of medical resources and estimation of relative direct medical costs for plerixafor therapy in association with G-CSF after chemotherapy.;Timepoint(s) of evaluation of this end point: 12 months