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

A pilot study investigating the combination of Mozobil® plus Neulasta® for Hematopoietic progenitor Cell (HPC-A) Mobilization in Patients with Lymphoma or Multiple Myeloma

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000116224

Enrollment

Registered

2009-02-18

Start date

2009-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A potential treatment for some blood cancer types is high dose therapy with stem cell transplantation. Stem cells are normally found in the bone marrow. Stem cells are collected from your bone marrow by ‘mobilising’ them into the blood stream. An apheresis machine removes blood from a vein in your arm or chest, collects off the stem cells and then returns the rest of your blood back to your vein. The collected stem cells are frozen and stored for later use. At the time of transplantation, a high dose of chemotherapy with or without radiotherapy would be given, and your frozen stem cells thawed and injected into your body (similar to a blood transfusion). These stem cells can help your bone marrow recover from the high dose therapy. Stem cells are usually mobilised from the bone marrow into the bloodstream using daily or twice-daily injections of a drug called Granulocyte-Colony Stimulating Factor (G-CSF), or filgrastim (Neupogen). This usually requires 6-10 days of injections. This project aims to test the combination of Mozobil® (a new agent for stem cell collection) with Neulasta® (a single dose, long-acting version of filgrastim) in the hope that it will produce better yields of stem cells in a shorter time with fewer injections.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results