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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Peripheral blood parameters

Outcome Time Frame:

Day 1 to Day 8 of the apheresis/treatment period

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

European Union: European Medicines Agency

Study ID:

ARD12858

NCT ID:

NCT01753453

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Multiple Myeloma
  • Hematopoietic stem cell transplantation
  • Tumour cell mobilization
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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