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).

NCT00838357 | Completed Phase 3

• 2 other identifiers: MOZ008082008-000689-21
• Study Type: interventional
• Target: 118
• Locations: 7 countries
• Sites: 26

Brief 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.

Conditions

Lymphoma (Non-Hodgkin's Lymphoma); Hodgkin's Disease or Multiple Myeloma; Front Line Mobilization; Transplantation

Keywords

Mobilisation stem cells; G-CSF Mobilisation Regimen; Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status

  After transplantation

• To examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status

  After transplantation

Study Arms (1)

Plerixafor

EXPERIMENTAL

Plerixafor added to a G-CSF Mobilisation regimen

Drug: Generic = Plerixafor

Interventions

Generic = Plerixafor DRUG

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

Plerixafor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (26)

Hôpital du Haut Lévêque

Bordeaux, France

Location

Hôpital Lyon Sud

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

CHU Hotel-Dieu Université de Nantes

Nantes, France

Location

Hôpital Saint-Louis

Paris, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Charité - Campus Benjamin Franklin

Berlin, Germany

Location

Klinikum der Universität zu Köln

Cologne, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, Germany

Location

Universitätsklinik Würzburg

Würzburg, Germany

Location

L. & A. Seragnoli, University of Bologna

Bologna, Italy

Location

Ospedale Ferrarotto

Catania, Italy

Location

Azienda Ospedaliera S. Martino

Genova, Italy

Location

VU Medisch Centrum

Amsterdam, Netherlands

Location

Hospital Santa Creu y Sant Pau

Barcelona, Spain

Location

Hospital Carlos-Haya

Málaga, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital la Fe

Valencia, Spain

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Gartnavel Hospital

Glasgow, United Kingdom

Location

St James's University Hospital

Leeds, United Kingdom

Location

King's college Hospital

London, United Kingdom

Location

Nottingham University NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Medical Monitor

  Genzyme Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: September 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

GB (4); ES (4); FR (6); NL (1); IT (3); DE (6); SE (2)