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

NCT ID: NCT01753453

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-09-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G-CSF alone

Patients will receive G-CSF for 5 consecutive days

Group Type: ACTIVE_COMPARATOR

Granulocyte-colony stimulating factor (G-CSF)

Intervention Type: DRUG

10 mcg/kg, solution, subcutaneous injection

G-CSF plus plerixafor

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

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: DRUG

240mcg/kg, solution, subcutaneous injection

Granulocyte-colony stimulating factor (G-CSF)

Intervention Type: DRUG

10 mcg/kg, solution, subcutaneous injection

Interventions

Plerixafor

240mcg/kg, solution, subcutaneous injection

Intervention Type: DRUG

Granulocyte-colony stimulating factor (G-CSF)

10 mcg/kg, solution, subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Mozobil,AMD3100

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 056002

Bruges, , Belgium

Investigational Site Number 233001

Tallinn, , Estonia

Investigational Site Number 440001

Vilnius, , Lithuania

Investigational Site Number 752001

Stockholm, , Sweden

Investigational Site Number 752002

Umeå, , Sweden

Countries

Belgium; Estonia; Lithuania; Sweden

Other Identifiers

MOZ23510

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004783-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARD12858

Identifier Type: -

Identifier Source: org_study_id