CompletedPhase 2

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

France13 participantsStarted 2007-08

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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

Trial details

NCT IDNCT00461955

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09

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