A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). (PREDICT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00838357
First received: February 5, 2009
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Lymphoma (Non-Hodgkin's Lymphoma)
Hodgkin's Disease or Multiple Myeloma
Front Line Mobilization
Transplantation
Drug: Generic = Plerixafor
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plerixafor and G−CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non−Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) − Safety Study in a General Autologous Transplant Population

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: After each dose of plerixafor ] [ Designated as safety issue: No ]
  • To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status [ Time Frame: After transplantation ] [ Designated as safety issue: No ]
  • To examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status [ Time Frame: After transplantation ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plerixafor
Plerixafor added to a G-CSF Mobilisation regimen
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838357

Locations
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, France
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, Germany
Italy
L. & A. Seragnoli, University of Bologna
Bologna, Italy
Ospedale Ferrarotto
Catania, Italy
Azienda Ospedaliera S. Martino
Genova, Italy
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands
Spain
Hospital Santa Creu y Sant Pau
Barcelona, Spain
Hospital Carlos-Haya
Malaga, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital la Fe
Valencia, Spain
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
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, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme Europe, B.V.
  More Information

No publications provided

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00838357     History of Changes
Other Study ID Numbers: MOZ00808, 2008-000689-21
Study First Received: February 5, 2009
Last Updated: November 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

Keywords provided by Genzyme, a Sanofi Company:
Mobilisation stem cells
G-CSF Mobilisation Regimen
Lymphoma
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014