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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.


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Multiple Myeloma, Lymphoma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PB CD34+ kinetics using VTP195183 plus G-CSF

Outcome Time Frame:

up to 28 days post study drug administration

Safety Issue:

No

Principal Investigator

Kirsten Herbert, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

05/09

NCT ID:

NCT00234169

Start Date:

October 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Lymphoma
  • Multiple Myeloma
  • Lymphoma
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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