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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

NCT01753453

CompletedPhase 2

Sponsor: Sanofi

Conditions: Multiple Myeloma

Interventions: Plerixafor, Granulocyte-colony stimulating factor (G-CSF)

Countries: Belgium, Estonia, Lithuania, Sweden

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (5)

Bruges, Belgium
Tallinn, Estonia
Vilnius, Lithuania
Stockholm, Sweden
Umeå, Sweden