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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor; Sargramostim

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.