AzTrials
AzTrials

Multiple MyelomaPhase 2ExpansionNCT00461955

Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation

A Phase 2 study testing autologous peripheral blood stem cell transplantation, ex vivo amplified in people with Multiple Myeloma, run by University Hospital, Bordeaux at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
autologous peripheral blood stem cell transplantation, ex vivo amplified
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteFrance
Study dates
Aug 2007to Aug 2009
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient between 18 and 65 years of age
  • Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation
  • Performance status: < 2 (Karnofsky > 70%)
  • Anticipated survival > 3 month
  • Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis.
  • Signed and dated informed consent

Who cannot join

  • Multiple Myeloma not requiring a treatment
  • Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
  • Positive serology for HIV, hepatitis C or hepatitis B
  • Hepato cellular insufficiency
  • Severe renal insufficiency defined by a creatine clearance < 30 ml/mn
  • Women pregnant or nursing, or effective absence of contraception
  • Antecedent of serious cardiac disease in the last 6 months.
  • Allergy known to the products derived from Escherichia Coli

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Haut-Leveque

    Pessac, 33604

Other trials in France

About this study

Official title: Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response

Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.

Read the detailed description

To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoietic reconstitution:

  1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets
  2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned
  3. Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.
Being tested
autologous peripheral blood stem cell transplantation, ex vivo amplified
Keywords
Symptomatic Multiple Myeloma, first line treatment, first autologous Stem Cell Transplantation, ex vivo amplified autologous peripheral blood stem cells
Medical subject headings
Multiple Myeloma

What participants receive

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

  • autologous peripheral blood stem cell transplantation, ex vivo amplifiedProcedure or surgery

    autologous peripheral blood stem cell transplantation, ex vivo amplified

Study groups in NCT00461955
Study groupRoleWhat they receive
1Experimentalautologous peripheral blood stem cell transplantation
Receives: Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified

What is being measured

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

  1. Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.

    Measured: at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft

Secondary outcomes (4)

  1. Immediate Toxicity of the injection of the amplified graft ;

    Measured: just after the injection of the amplified graft

  2. Quantitative immunological Reconstitution

    Measured: at day 30, 100, 180, 270, 360 after the injection and then every 6 months

  3. Stability of the hematopoiesis in the long term

    Measured: at 1, 3, 6, 9 and 12 months after the graft

  4. Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.

    Measured: at 1, 3, 6, 9 and 12 months after the injection

Timeline

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

  1. First posted18 Apr 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2008
  4. Study completionAug 2009

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461955
Sponsor's protocol ID
CHUBX 2000/04
Other IDs
TC6A10A11A12
Acronym
Expansion
Status last verified
Nov 2010
First submitted
17 Apr 2007
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No

Publications

  • Bernstein ID, Andrews RG, Zsebo KM. Recombinant human stem cell factor enhances the formation of colonies by CD34+ and CD34+lin- cells, and the generation of colony-forming cell progeny from CD34+lin- cells cultured with interleukin-3, granulocyte colony-stimulating factor, or granulocyte-macrophage colony-stimulating factor. Blood. 1991 Jun 1;77(11):2316-21.

    PubMed 1710148

  • Bodine DM, Crosier PS, Clark SC. Effects of hematopoietic growth factors on the survival of primitive stem cells in liquid suspension culture. Blood. 1991 Aug 15;78(4):914-20.

    PubMed 1714328

  • Boiron JM, Marit G, Faberes C, Cony-Makhoul P, Foures C, Ferrer AM, Cristol G, Sarrat A, Girault D, Reiffers J. Collection of peripheral blood stem cells in multiple myeloma following single high-dose cyclophosphamide with and without recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Bone Marrow Transplant. 1993 Jul;12(1):49-55.

    PubMed 8104070

  • Brandt J, Srour EF, van Besien K, Briddell RA, Hoffman R. Cytokine-dependent long-term culture of highly enriched precursors of hematopoietic progenitor cells from human bone marrow. J Clin Invest. 1990 Sep;86(3):932-41. doi: 10.1172/JCI114795.

    PubMed 1697607

  • Brugger W, Heimfeld S, Berenson RJ, Mertelsmann R, Kanz L. Reconstitution of hematopoiesis after high-dose chemotherapy by autologous progenitor cells generated ex vivo. N Engl J Med. 1995 Aug 3;333(5):283-7. doi: 10.1056/NEJM199508033330503.

    PubMed 7541111

  • Haylock DN, To LB, Dowse TL, Juttner CA, Simmons PJ. Ex vivo expansion and maturation of peripheral blood CD34+ cells into the myeloid lineage. Blood. 1992 Sep 15;80(6):1405-12.

    PubMed 1381625

  • Iscove NN, Shaw AR, Keller G. Net increase of pluripotential hematopoietic precursors in suspension culture in response to IL-1 and IL-3. J Immunol. 1989 Apr 1;142(7):2332-7.

    PubMed 2784460

  • Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31. doi: 10.1111/j.1537-2995.2005.00675.x.

    PubMed 16398741

  • Kobayashi M, Imamura M, Gotohda Y, Maeda S, Iwasaki H, Sakurada K, Kasai M, Hapel AJ, Miyazaki T. Synergistic effects of interleukin-1 beta and interleukin-3 on the expansion of human hematopoietic progenitor cells in liquid cultures. Blood. 1991 Oct 15;78(8):1947-53.

    PubMed 1717075

  • Moore MA. Review: Stratton Lecture 1990. Clinical implications of positive and negative hematopoietic stem cell regulators. Blood. 1991 Jul 1;78(1):1-19. No abstract available.

    PubMed 2070044

  • Moore MA. Hematopoietic reconstruction: new approaches. Clin Cancer Res. 1995 Jan;1(1):3-9. No abstract available.

    PubMed 9815881

  • Muench MO, Moore MA. Accelerated recovery of peripheral blood cell counts in mice transplanted with in vitro cytokine-expanded hematopoietic progenitors. Exp Hematol. 1992 Jun;20(5):611-8.

    PubMed 1587307

  • Muench MO, Schneider JG, Moore MA. Interactions among colony-stimulating factors, IL-1 beta, IL-6, and kit-ligand in the regulation of primitive murine hematopoietic cells. Exp Hematol. 1992 Mar;20(3):339-49.

    PubMed 1373685

  • Reiffers J, Marit G, Vezon G, Cony-Makhoul P, Boiron JM, Montastruc M, Rice A, Broustet A. Autologous blood stem cell grafting in hematological malignancies. Present status and future directions. Transfus Sci. 1992;13(4):399-405. doi: 10.1016/0955-3886(92)90024-B. No abstract available.

    PubMed 10147738

  • Reiffers J, Faberes C, Boiron JM, Marit G, Foures C, Ferrer AM, Cony-Makhoul P, Puntous M, Bernard P, Vezon G, et al. Peripheral blood progenitor cell transplantation in 118 patients with hematological malignancies: analysis of factors affecting the rate of engraftment. J Hematother. 1994 Fall;3(3):185-91. doi: 10.1089/scd.1.1994.3.185.

    PubMed 7530133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing autologous peripheral blood stem cell transplantation, ex vivo amplified in people with Multiple Myeloma, run by University Hospital, Bordeaux at 1 site in France.

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 6 inclusion and 8 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 7 Aug 2026. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion. (time frame: at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft). 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 NCT00461955, which also lists 18 linked publications.

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 7 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in