An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01753453
First received: December 17, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).

Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.


Condition Intervention Phase
Multiple Myeloma
Drug: Plerixafor
Drug: Granulocyte-colony stimulating factor (G-CSF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells [ Time Frame: Day 1 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: Yes ]
    Peripheral blood parameters

  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: Yes ]
    Peripheral blood parameters

  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: Yes ]
    Peripheral blood parameters

  • The change in tumor cell mobilization(TCM) in the peripheral blood [ Time Frame: Day 4 pre-G-CSF to Day 5 pre-G-CSF ] [ Designated as safety issue: Yes ]
    Peripheral blood parameters

  • The number of myeloma tumor cells per patient at each apheresis [ Time Frame: Day 1 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: Yes ]
    Apheresis product parameters

  • The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: Yes ]
    Apheresis product parameters


Secondary Outcome Measures:
  • CD34+ stem cell yield in the apheresis product [ Time Frame: Day 1 to Day 8 of the apheresis/treatment period ] [ Designated as safety issue: No ]
  • The number of patients that proceed to transplantation [ Time Frame: Up to 2 months after final apheresis ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Day 100 post transplant and up to 2 years post first-G-CSF dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: G-CSF alone
Patients will receive G-CSF for 5 consecutive days
Drug: Granulocyte-colony stimulating factor (G-CSF)
10 mcg/kg, solution, subcutaneous injection
Experimental: G-CSF plus plerixafor
Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF
Drug: Plerixafor
240mcg/kg, solution, subcutaneous injection
Other Name: Mozobil,AMD3100
Drug: Granulocyte-colony stimulating factor (G-CSF)
10 mcg/kg, solution, subcutaneous injection

  Eligibility

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

Inclusion Criteria:

  • Patients with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers.

Exclusion Criteria:

  • Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
  • Had prior allogeneic or autologous transplantation.
  • Less than 3 to 6 weeks since last anti-cancer therapy.
  • Chemotherapy for mobilization is not allowed.
  • Has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF.
  • Was treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
  • Has previously received plerixafor.
  • Is known to be HIV positive.
  • Has active hepatitis B or hepatitis C.
  • Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
  • Has hypercalcaemia as evidenced by >1 mg/dL above upper limit of normal (ULN).
  • Previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
  • Has central nervous system involvement including brain metastases or leptomeningeal disease.
  • Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality.
  • Has co-morbid condition(s), which may render the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol.
  • Has a white blood cell (WBC) count <2.5 x 10^9/L.
  • Has an absolute neutrophil count (ANC) <1.5 x 10^9/L.
  • Has a platelet count <100 x 10^9/L.
  • Has an estimated creatine clearance ≤50 mL/min.
  • Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x ULN.
  • Does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation.
  • Pregnant or breastfeeding women.
  • Does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment.
  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: NCT01753453

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
Belgium
Investigational Site Number 056002 Recruiting
Brugge, Belgium, 8000
Investigational Site Number 056001 Recruiting
Liège, Belgium, 4000
Estonia
Investigational Site Number 233001 Recruiting
Tallinn, Estonia, 13419
Lithuania
Investigational Site Number 440001 Recruiting
Vilnius, Lithuania, LT-08661
Sweden
Investigational Site Number 752001 Recruiting
Stockholm, Sweden, 14186
Investigational Site Number 752002 Recruiting
Umeå, Sweden, 901 85
Sponsors and Collaborators
Sanofi
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01753453     History of Changes
Other Study ID Numbers: ARD12858, MOZ23510, 2011-004783-30
Study First Received: December 17, 2012
Last Updated: May 15, 2014
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Sanofi:
Hematopoietic stem cell transplantation
Tumour cell mobilization

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
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
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014