Status:
COMPLETED
A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Multiple Myeloma
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram ar...
Eligibility Criteria
Inclusion
- Age 18-70
- Histologically proven multiple myeloma or lymphoma
- Intent of treating physician to proceed to high dose therapy and autologous transplantation
- Not currently receiving thalidomide (within 1 week of commencing VTP195813 or G-CSF), cytotoxic agents or high dose prednisolone or Dexamethasone (at doses greater than 15 mg prednisolone or equivalent per day)
- Multiple myeloma patients must be taking regular bisphosphonate therapy
- Absolute neutrophil count between 1.5 and 10 x 109/L
- ECOG performance status ? 2
- Life expectancy of at least 2 months
- Written informed consent signed by patient or legally authorized representative
Exclusion
- Active infection or a fever \> 38.2 degrees C (fever due to B symptoms in lymphoma patients will not exclude a patient)
- Use within the previous 30 days of other vitamin A preparations within the last 30 days (including oral vitamin supplements, oral retinoids for acne or other skin disorders, bexarotene, or topical vitamin A preparations)
- Pregnancy or breast feeding. Women of child-bearing potential, admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception during the study and for at least one month after completion of study drugs) and are to undergo a pregnancy test
- Significant non-malignant disease including HIV infection, uncontrolled hypertension (diastolic blood pressures \> 115 mmHg), unstable angina
- Known allergy to E.coli-derived products
- Current treatment with tetracycline antibiotics
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00234169
Start Date
October 1 2005
End Date
January 1 2008
Last Update
May 10 2012
Active Locations (1)
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1
Peter MacCallum Cancer centre
Melbourne, Victoria, Australia, 3002