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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00838357
Other study ID # MOZ00808
Secondary ID 2008-000689-21
Status Completed
Phase Phase 3
First received February 5, 2009
Last updated March 19, 2015
Start date September 2008
Est. completion date November 2010

Study information

Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Italy: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.


Description:

Patients with advanced or treatment-refractory Multiple Myeloma (MM), Hodgkin's Disease (HD) and Non-Hodgkin's Lymphoma (NHL) may be successfully treated with high dose chemotherapy followed by autologous transplantation of peripheral blood stem cells (PBSCs). Successful engraftment of peripheral blood stem cells (PBSCs) is well correlated with the number of CD34+ cells infused.

Stem cell collection with plerixafor could have a major benefit by increasing the circulating number of PBSCs and decreasing the number of apheresis sessions required to collect a sufficient number of PBSCs for transplant.

This is a multi-centre, open label, single-arm study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.

Screening for eligibility will take place up to 30 days before the first dose of G-CSF. Patients will receive a stem cell mobilisation regimen consisting of plerixafor and G-CSF. Patients will be given G-CSF for 4 consecutive days in the morning. Starting on the evening of Day 4, plerixafor will be administered subcutaneously (SC). The plerixafor dose will be timed to allow for a 10- to 11-hour interval between the plerixafor dosing and the initiation of apheresis. Patients may continue to receive the evening dose of plerixafor then G-CSF the next morning followed by apheresis for up to a total of 5 apheresis procedures until a minimum of at least 5 x 106 CD34+ cells/kg for NHL/HD or 6 x 106 CD34+ cells/kg for MM are collected. More cells may be collected if done within the 5 apheresis procedures. Stem cell collection will take place using standard procedures.

Following the last apheresis, patients will undergo pre-transplant myeloablative chemotherapy followed by transplantation of the collected autologous stem cells, using the established protocols and procedures at each site.

Peripheral blood samples will be collected for determining the number of CD34+ cells in the peripheral blood. In addition, a sample will be obtained from each apheresis product to determine the quantity of CD34+ cells collected after each procedure.

Safety data will be reported according to guidelines provided in the protocol. Adverse event (AE) guidance is summarised in the protocol. Investigators will grade AEs using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent engraftment and graft status. Patients who undergo haematopoietic stem cell transplantation will be monitored for graft status at 100 days, 6 months, and 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)

- Eligible and planned for an autologous haematopoietic stem cell transplantation

- Written informed consent

- At least 18 years of age (inclusive)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- White blood cell (WBC) count =2.5 x 10^9/L

- Absolute neutrophil count (ANC) =1.5 x 10^9 /L

- Platelet count =100 x 10^9/L

- Serum creatinine =2.2 mg/dL

- 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)

- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant

- All patients must agree to use a highly effective method of contraception whilst 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). 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 interaction of plerixafor with hormonal contraceptives is not known.

Exclusion Criteria:

- History of any acute or chronic leukaemia (including myelodysplastic syndrome)

- Prior allogeneic transplantation or more than one prior autologous transplantation

- Failed previous CD34+ cell collection attempts (either due to insufficient yield in apheresis product, or ineligible for apheresis because of inadequate mobilisation of CD34+ cells into peripheral blood)

- Less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy with nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free interval of at least 2 half-lives should be considered) with the exception of ; Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) which is allowed up to 7 days prior to the first dose of G-CSF.

- Bone marrow involvement >20% assessed based on the most recent bone marrow aspirate or biopsy

- Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilisation

- Known to be human immunodeficiency virus (HIV) positive

- Active hepatitis B or hepatitis C

- Acute infection (febrile, i.e., temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF

- Hypercalcaemia as evidenced by >1 mg/dL above ULN

- Previously received investigational therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase

- Central nervous system involvement including brain metastases or leptomeningeal disease

- Pregnant or nursing women

- Electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischaemia 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.

- Co-morbid condition(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Generic = Plerixafor
240µg/kg administered as an SC injection 10 to 11 hours prior to initiation of apheresis. Daily administration for 1 up to 5 consecutive days

Locations

Country Name City State
France Hôpital du Haut Lévêque Bordeaux
France Hôpital Lyon Sud Lyon
France Institut Paoli Calmettes Marseille
France CHU Hotel-Dieu Université de Nantes Nantes
France Hôpital Saint-Louis Paris
France Institut Gustave Roussy Villejuif
Germany Charité - Campus Benjamin Franklin Berlin
Germany Klinikum der Universität zu Köln Cologne
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Klinikum Nürnberg Nord Nürnberg
Germany Universitätsklinik Würzburg Würzburg
Italy L. & A. Seragnoli, University of Bologna Bologna
Italy Ospedale Ferrarotto Catania
Italy Azienda Ospedaliera S. Martino Genova
Netherlands VU Medisch Centrum Amsterdam
Spain Hospital Santa Creu y Sant Pau Barcelona
Spain Hospital Carlos-Haya Malaga
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital la Fe Valencia
Sweden Karolinska Universitetssjukhuset Huddinge Stockholm
Sweden Akademiska Sjukhuset Uppsala
United Kingdom Gartnavel Hospital Glasgow
United Kingdom St James's University Hospital Leeds
United Kingdom King's college Hospital London
United Kingdom Nottingham University NHS Trust Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant 24 months Yes
Secondary To assess efficacy of plerixafor and granulocyte-colony stimulating factor (G-CSF) as a mobilisation regimen as measured by the number of CD34+ cells collected in each apheresis session After each dose of plerixafor No
Secondary To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status After transplantation No
Secondary To examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status After transplantation No
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