NCT01753453

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Jun 2013

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

December 17, 2012

Last Update Submit

February 19, 2021

Conditions

Multiple Myeloma

Keywords

Hematopoietic stem cell transplantationTumour cell mobilization

Outcome Measures

Primary Outcomes (6)

  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells

    Peripheral blood parameters

    Day 1 to Day 8 of the apheresis/treatment period

  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights

    Peripheral blood parameters

    Day 5 to Day 8 of the apheresis/treatment period

  • The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight

    Peripheral blood parameters

    Day 5 to Day 8 of the apheresis/treatment period

  • The change in tumor cell mobilization(TCM) in the peripheral blood

    Peripheral blood parameters

    Day 4 pre-G-CSF to Day 5 pre-G-CSF

  • The number of myeloma tumor cells per patient at each apheresis

    Apheresis product parameters

    Day 1 to Day 8 of the apheresis/treatment period

  • The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product

    Apheresis product parameters

    Day 5 to Day 8 of the apheresis/treatment period

Secondary Outcomes (3)

  • CD34+ stem cell yield in the apheresis product

    Day 1 to Day 8 of the apheresis/treatment period

  • The number of patients that proceed to transplantation

    Up to 2 months after final apheresis

  • Overall survival

    Day 100 post transplant and up to 2 years post first-G-CSF dose

Study Arms (2)

G-CSF alone

ACTIVE COMPARATOR

Patients will receive G-CSF for 5 consecutive days

Drug: Granulocyte-colony stimulating factor (G-CSF)

G-CSF plus plerixafor

EXPERIMENTAL

Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF

Drug: PlerixaforDrug: Granulocyte-colony stimulating factor (G-CSF)

Interventions

PlerixaforDRUG

240mcg/kg, solution, subcutaneous injection

Also known as: Mozobil,AMD3100
G-CSF plus plerixafor
Granulocyte-colony stimulating factor (G-CSF)DRUG

10 mcg/kg, solution, subcutaneous injection

G-CSF aloneG-CSF plus plerixafor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigational Site Number 056002

Bruges, B-8000, Belgium

Location

Investigational Site Number 233001

Tallinn, 13419, Estonia

Location

Investigational Site Number 440001

Vilnius, LT-08661, Lithuania

Location

Investigational Site Number 752001

Stockholm, 14186, Sweden

Location

Investigational Site Number 752002

Umeå, 901 85, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plerixaforGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

June 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

BE(1)SE(2)ES(1)LI(1)