Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma

NCT02221479 | Completed Phase 2

• 2 other identifiers: ACT13710U1111-1152-4403
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10\^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone. Secondary Objectives:

• To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients.
• To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis.
• To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10\^6 CD34+ cells/kg.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis

  Day 5 to Day 8 of the apheresis/treatment period

Secondary Outcomes (7)

• Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis

  Day 5 to Day 8 of the apheresis/treatment period

• Number of days of apheresis to collect 6 x10^6 cells/kg CD34+ cells

  Day 5 to Day 8 of the apheresis/treatment period

• Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells

  Day 5 to Day 8 of the apheresis/treatment period

• Total number of CD34+ cells/kg collected over up to 4 apheresis

  Day 5 to Day 8 of the apheresis/treatment period

• The relative increase (ratio) of peripheral blood CD34+ cell count (cells/μL)

  From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only

Study Arms (2)

Granulocyte colony-stimulating factor (G-CSF) alone

ACTIVE COMPARATOR

G-CSF administered up to 8 days

Drug: Filgrastim

G-CSF plus plerixafor

EXPERIMENTAL

G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)

Drug: plerixafor GZ316455; Drug: Filgrastim

Interventions

plerixafor GZ316455 DRUG

Pharmaceutical form:vial Route of administration: subcutaneous injection

Also known as: Mozobil

G-CSF plus plerixafor

Filgrastim DRUG

Pharmaceutical form:vial Route of administration: subcutaneous injection

G-CSF plus plerixafor; Granulocyte colony-stimulating factor (G-CSF) alone

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 75.
• Japanese participants with histological or pathological diagnosis of MM.
• First or second complete response (CR) or partial response (PR).

You may not qualify if:

• Leukemia participants.
• Myelodysplastic syndrome (MDS) participants.
• Less than 2 weeks since completion of last cycle of chemotherapy.
• Failed previous hematopoietic stem cell (HSC) collections or collection attempts.
• Prior autologous or allogeneic transplant.
• Diagnosis of another malignancy.
• Known hypersensitivity to plerixafor, G-CSF or their components.
• Bone marrow involvement greater than 10%.
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 1.
• Not yet recovered from all acute toxic effects of prior Chemotherapy.
• White blood cell (WBC) count less than or equal to 2.5 × 10\^9 cells/L.
• Absolute neutrophil count (ANC) less than or equal to 1.5 × 10\^9 cells /L.
• Platelet count less than or equal to 100 × 10\^9 cells /L.
• Creatinine clearance less than 50 mL/min.
• Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than or equal to 2.5 x upper limit of normal,Total Bilirubin greater than or equal to 2.5 x upper limit of normal.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (5)

Investigational Site Number 392105

Kamogawa-Shi, Japan

Location

Investigational Site Number 392103

Kyoto, Japan

Location

Investigational Site Number 392102

Nagoya, Japan

Location

Investigational Site Number 392104

Okayama, Japan

Location

Investigational Site Number 392101

Shibuya-Ku, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plerixafor; Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological 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: August 19, 2014
• First Posted: August 20, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

JP (5)