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A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma

Phase 1
18 Years
70 Years
Not Enrolling
Multiple Myeloma, Cutaneous Lymphoma

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Trial Information

A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma

HSPC mobilization is normally achieved using cytokines such as G-CSF, or occasionally
GM-CSF, often in combination with myelosuppressive chemotherapy.

Studies in the mouse model have shown that retinoids (vitamin A derivatives) can be combined
with G-CSF, and that this combination synergizes to enhance HSPC mobilization over that seen
with G-CSF alone.

This trial aims to assess the safety and mobilization efficacy of combining mobilizing doses
of G-CSF with a standard dose of ATRA, using a treatment regimen derived from the earlier
murine studies.

In this phase I pilot study, six patients with multiple myeloma or cutaneous lymphoma will
be treated with ATRA plus G-CSF, and safety and toxicity data collected for the two week
study drug period plus a further two weeks' follow-up. The primary endpoint is safety and
toxicity, the secondary endpoint is an observation of the mobilization efficacy as
demonstrated by CD34+ cell counts over the study period. Patients will not undergo stem cell
collection during this study, as this is purely an observational study. Participating
patients will not be those who would normally be scheduled for stem cell collection and
transplantation in the near future, but rather patients with stable disease who are not
candidates for imminent transplantation, or who have collected adequate HSPC on previous
mobilization attempts and are currently being observed.

Cutaneous lymphoma and multiple myeloma are chosen as suitable disease states for this study
as there is in vitro evidence of a possible disease benefit of retinoids in these disorders.
If disease response is noted during the study or follow up period, ongoing ATRA will be
offered at the discretion of the treating physician.

Inclusion Criteria:

- likely to comply with study protocol

- age of 18-70

- histologically proven multiple myeloma or lymphoma

- not currently receiving cytotoxic agents however thalidomide, prednisolone,
dexamethasone are allowable

- multiple myeloma patients must be receiving regular bisphosphonates

- absolute neutrophil count between 1.5 and 10.0 x 10^9/L

- ECOG performance status
- life expectancy of at least two months

- written informed consent signed by patient or legally authorised representative

Exclusion Criteria:

- use of other vitamin A preparations within the last 30 days

- active infection or fever >/= 38.2 degrees celsius

- 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) and are to undergo a pregnancy test. Oral contraception must not
include low-dose progestogens

- known allergy to E.coli derived products

- current treatment with tetracycline antibiotics

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity data (NCI-CTC version 2.0 criteria)

Principal Investigator

Kirsten E Herbert, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Center


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

March 2005

Completion Date:

May 2005

Related Keywords:

  • Multiple Myeloma
  • Cutaneous Lymphoma
  • mobilization
  • ATRA
  • G-CSF
  • filgrastim
  • retinoids
  • stem cell mobilization
  • hematopoietic stem and progenitor cells
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell