A study to investigate whether the combination of Mozobil and Neulasta is safe and effective for mobilization of blood stem cells for the treatment of lymphoma and multiple myeloma

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000116224
• Date of registration: 18/02/2009
• Prospective Registration: Yes
• Primary sponsor: Peter MacCallum Cancer Centre
• Public title: A study to investigate whether the combination of Mozobil and Neulasta is safe and effective for mobilization of blood stem cells for the treatment of lymphoma and multiple myeloma
• Scientific title: A pilot study investigating the combination of Mozobil® plus Neulasta® for Hematopoietic progenitor Cell (HPC-A) Mobilization in Patients with Lymphoma or Multiple Myeloma
• Date of first enrolment: 01/06/2009
• Target sample size: 12
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12609000116224.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Kirsten Herbert

• Name: Dr Kirsten Herbert

Key inclusion & exclusion criteria

Inclusion criteria: 1. Histologically proven multiple myeloma or lymphoproliferative disease
2. Absolute neutrophil count between 1.5 and 10.0 x 10^9/L
3. Adequate renal function: calculated creatinine clearance >/= 30 ml/min
4. Eastern Cooperative Oncology Group (ECOG) performance status >/=2
5. Life expectancy of at least 2 months
6. Able to give written informed consent
7.Patient able to make arrangements for injection of study drugs (self, family member, visiting nurse, etc)
Exclusion criteria: 1. Active infection (fever due to B symptoms in lymphoma patients will not exclude a patient)
2. Pregnancy or breast feeding.
3. Significant non-malignant disease including Human Immunodeficieny Virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > 115 mmHg), unstable angina.
4. Known allergy to E.coli-derived products
5. Patients predicted to be ‘adequate mobilizers must have the absence of specific risk factors for poor mobilization

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Myeloma

Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Lymphoma;Multiple myeloma;
Lymphoma
Multiple myeloma

Intervention(s)

Pegfilgrastim (Neulasta®) 6mg subcutaneous injection once only on day 1,
Plerixafor (Mozobil®) 240ug/kg subcutaneous injection on day 3. Additional plerixafor doses (240 ug/kg) days 4, 5 and 6 if target apheresis yields not reached.

Primary Outcome(s)

Peripheral blood CD34+ cell counts. Measured by flow cytometry cytometric assessment of cells expressing the CD34+ antigen.[Baseline, then daily from day 3 to day 7 or until target CD34+ cell yield is reached (whichever occurs first)]

Toxicity/adverse events. The National Cancer Institute (USA) Common Toxicitiy Criteria for Adverse Eevents (CTCAE) version 3 is the instrument used to designate and grade adverse events.[Baseline, day 3, day 4 , day 11 and day 28 (end) of study]

Secondary Outcome(s)

Mobilization efficacy defined as:
"successful" (collection of a minimum > 2x10^6/kg CD34+ cells),
"optimal" (collection of > 5x10^6/kg CD34+ cells), "unsuccessful" (collection of <2x10^6/kg CD34+ cells) or "mobilization failure" (patient never achieved a peripheral blood CD34+ count of > 5x10^6/L)[Mobilization status will be assessed at day 7]

Source(s) of Monetary Support

Genzyme Australasia Pty Ltd

Ethics review

Status: Not approved
Approval date:
Contact: