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Clinical Trials/EUCTR2011-004783-30-SE
EUCTR2011-004783-30-SEActive, not recruitingPhase 1

A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients

Sanofi aventis recherche et développement0 sites20 target enrollmentStarted: January 7, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients with a diagnosis of MM in partial or complete response, who are to undergo an autologous HSCT and could be considered potentially poor mobilizers.
  • •A potentially poor mobilizer is defined as a person who, in the judgment of the investigator prior to study entry, may not mobilize successfully for reasons such as prior lenalidomide use.
  • •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 14
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

  • •The patient does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • •The patient has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
  • •The patient had prior allogeneic or autologous transplantation.
  • •The patient is less than 3 to 6 weeks since last anti-cancer therapy.
  • •Chemotherapy for mobilization is not allowed. Note: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose
  • •The patient has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF.
  • •The patient was treated with G-CSF or other cytokine within 14 days prior to the first dose of GCSF
  • •for mobilization.
  • •The patient has previously received plerixafor.
  • •The patient is known to be HIV positive.
  • •The patient has active hepatitis B or hepatitis C.
  • •The patient has an acute infection (febrile, ie, temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
  • •The patient has hypercalcaemia as evidenced by >1 mg/dL above ULN.
  • •The patient previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
  • •The patient has central nervous system involvement including brain metastases or leptomeningeal disease.
  • •The patient has an electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other
  • •conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
  • •The patient has co-morbid condition(s), which in the opinion of the investigator, renders the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol.
  • •The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study
  • •The patient has a white blood cell (WBC) count <2.5 x _109/L.
  • •The patient has an absolute neutrophil count (ANC) <1.5 x _109/L.
  • •The patient has a platelet count <100 x 109/L.
  • •The patient has an estimated creatine clearance =50 mL/min.
  • •The patient has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin =2.5 x _upper limit of normal (ULN).
  • •The patient does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation, ie, eligible by institutional standards for autologous stem cell
  • •transplant.
  • •Pregnant or breastfeeding women
  • •The patient does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment (including both female patients of childbearing potential and male patients with partners of child-bearing potential). Effective birth control includes:
  • •a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method, or
  • •b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interactio

Investigators

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