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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01753453
Collaborator
Genzyme, a Sanofi Company (Industry)
23
5
2
39
4.6
0.1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Mozobil,AMD3100
  • Drug: Granulocyte-colony stimulating factor (G-CSF)
    10 mcg/kg, solution, subcutaneous injection

    Outcome Measures

    Primary Outcome Measures

    1. The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells [Day 1 to Day 8 of the apheresis/treatment period]

      Peripheral blood parameters

    2. The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights [Day 5 to Day 8 of the apheresis/treatment period]

      Peripheral blood parameters

    3. The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight [Day 5 to Day 8 of the apheresis/treatment period]

      Peripheral blood parameters

    4. The change in tumor cell mobilization(TCM) in the peripheral blood [Day 4 pre-G-CSF to Day 5 pre-G-CSF]

      Peripheral blood parameters

    5. The number of myeloma tumor cells per patient at each apheresis [Day 1 to Day 8 of the apheresis/treatment period]

      Apheresis product parameters

    6. The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product [Day 5 to Day 8 of the apheresis/treatment period]

      Apheresis product parameters

    Secondary Outcome Measures

    1. CD34+ stem cell yield in the apheresis product [Day 1 to Day 8 of the apheresis/treatment period]

    2. The number of patients that proceed to transplantation [Up to 2 months after final apheresis]

    3. Overall survival [Day 100 post transplant and up to 2 years post first-G-CSF dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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
    • 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

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 056002 Brugge Belgium B-8000
    2 Investigational Site Number 233001 Tallinn Estonia 13419
    3 Investigational Site Number 440001 Vilnius Lithuania LT-08661
    4 Investigational Site Number 752001 Stockholm Sweden 14186
    5 Investigational Site Number 752002 Umeå Sweden 901 85

    Sponsors and Collaborators

    • Sanofi
    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01753453
    Other Study ID Numbers:
    • ARD12858
    • MOZ23510
    • 2011-004783-30
    First Posted:
    Dec 20, 2012
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sanofi
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2021