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Multiple MyelomaPhase 1NCT00400556

ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells

A Phase 1 study testing ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination in people with Multiple Myeloma and Cutaneous Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers. HSPC are collected from the bloodstream after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma, Cutaneous Lymphoma
What is being tested?
ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination
How many people
6 participants
Where
1 siteAustralia
Study dates
Mar 2005to May 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • ECOG performance status </= 3
  • life expectancy of at least two months
  • written informed consent signed by patient or legally authorised representative

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Center

    East Melbourne, Victoria, 3002

Other trials in Australia

About this study

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

Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers.

  • HSPC are collected from the bloodstream after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called mobilization
  • between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using current mobilization techniques
  • this study aims to assess the safety of combining a derivative of vitamin A, ATRA with G-CSF (the drug most commonly used to mobilize HSPC)
  • ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study is needed to assess the safety of this combination, and whether it successfully mobilizes HSPC
Read the detailed description

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.

Being tested
ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination
Keywords
mobilization, ATRA, G-CSF, filgrastim, retinoids, stem cell mobilization, hematopoietic stem and progenitor cells
Medical subject headings
Multiple Myeloma, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combinationDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity data (NCI-CTC version 2.0 criteria)

  2. skin toxicity

  3. hepatotoxicity

  4. mucosal toxicity

  5. hematologic toxicity

  6. neurologic toxicity

  7. treatment response

  8. CD34+ cell count peak level

  9. time to CD34+ count peak level

  10. time to reach level >5 x 10^6.L

  11. area under curve for duration of time spent with CD34+ count >5 x 10^6/L

  12. peripheral blood colony forming unit assays

  13. peak CFU-GEMM level

  14. time to peak CFU-GEMM level

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2006 (estimated)
  2. Study startMar 2005
  3. Study completionMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00400556
Sponsor's protocol ID
04/24
Status last verified
Nov 2006
First submitted
15 Nov 2006
Last updated
17 Nov 2006
Results posted
No

Publications

  • Herbert KE, Walkley CR, Winkler IG, Hendy J, Olsen GH, Yuan YD, Chandraratna RA, Prince HM, Levesque JP, Purton LE. Granulocyte colony-stimulating factor and an RARalpha specific agonist, VTP195183, synergize to enhance the mobilization of hematopoietic progenitor cells. Transplantation. 2007 Feb 27;83(4):375-84. doi: 10.1097/01.tp.0000251376.75347.b4.

    PubMed 17318068

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination in people with Multiple Myeloma and Cutaneous Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity data (NCI-CTC version 2.0 criteria). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00400556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2006.

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