A Phase I/II Study of Peripheral Blood Progenitor Cells Mobilisation With VTP195183 Plus G-CSF Compared to Mobilisation With G-CSF Alone in Patients With Multiple Myeloma and Lymphoma.
Inclusion Criteria:
1. Age 18-70
2. Histologically proven multiple myeloma or lymphoma
3. Intent of treating physician to proceed to high dose therapy and autologous
transplantation
4. 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)
5. Multiple myeloma patients must be taking regular bisphosphonate therapy
6. Absolute neutrophil count between 1.5 and 10 x 109/L
7. ECOG performance status ? 2
8. Life expectancy of at least 2 months
9. Written informed consent signed by patient or legally authorized representative
Exclusion Criteria:
1. Active infection or a fever > 38.2 degrees C (fever due to B symptoms in lymphoma
patients will not exclude a patient)
2. 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)
3. 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
4. Significant non-malignant disease including HIV infection, uncontrolled hypertension
(diastolic blood pressures > 115 mmHg), unstable angina
5. Known allergy to E.coli-derived products
6. Current treatment with tetracycline antibiotics