Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT00234169
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00234169
Study Brief:
Protocol Section:
NCT00234169