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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753453
• Other study ID #: ARD12858
• Secondary ID: MOZ235102011-004
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2021
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Plerixafor
240mcg/kg, solution, subcutaneous injection
• Granulocyte-colony stimulating factor (G-CSF)
10 mcg/kg, solution, subcutaneous injection

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056002	Brugge
Estonia	Investigational Site Number 233001	Tallinn
Lithuania	Investigational Site Number 440001	Vilnius
Sweden	Investigational Site Number 752001	Stockholm
Sweden	Investigational Site Number 752002	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  Estonia,  Lithuania,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells	Peripheral blood parameters	Day 1 to Day 8 of the apheresis/treatment period
Primary	The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights	Peripheral blood parameters	Day 5 to Day 8 of the apheresis/treatment period
Primary	The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight	Peripheral blood parameters	Day 5 to Day 8 of the apheresis/treatment period
Primary	The change in tumor cell mobilization(TCM) in the peripheral blood	Peripheral blood parameters	Day 4 pre-G-CSF to Day 5 pre-G-CSF
Primary	The number of myeloma tumor cells per patient at each apheresis	Apheresis product parameters	Day 1 to Day 8 of the apheresis/treatment period
Primary	The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product	Apheresis product parameters	Day 5 to Day 8 of the apheresis/treatment period
Secondary	CD34+ stem cell yield in the apheresis product		Day 1 to Day 8 of the apheresis/treatment period
Secondary	The number of patients that proceed to transplantation		Up to 2 months after final apheresis
Secondary	Overall survival		Day 100 post transplant and up to 2 years post first-G-CSF dose