NCT03406091Completed
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients: Prospective Product Registry
Source: ClinicalTrials.gov · Last updated 20 Feb 2024
Brief summary (registry, in English)
The study is an italian multicentric and will be conducted in 20 centers. The aim of this study is to evaluate poor mobilizer (PM) rate in newly diagnosed MM patients who are mobilized with cyclophosphamide and G-CSF and plerixafor on demand. Plerixafor is a specific reversible inhibitor of the chemokine receptor CXCR4 and prevents the binding of its ligand stromal cell derived factor SDF-1α also known as CXCL12, thereby releasing hematopoietic stem cells into the circulation.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 15 Jan 2018
- Start date
- 26 Nov 2015
- Primary completion date
- 19 Jan 2021
- Lead sponsor
- Fondazione EMN Italy Onlus
- Diseases
- Multiple myeloma
- NCT number
- NCT03406091
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 26 Nov 2015 to the primary completion date, 19 Jan 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic or autologous transplantation.
- Prior failed mobilization attempt.
- Pregnant or nursing women or patients unwilling to have adequate contraception up to 3 months after end of treatment with plerixafor
- Acute infection (febrile, i.e. temperature \> 38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
- Splenectomised or splenic irradiation.
- Treatment with G-CSF or other cytokine within 2 weeks prior to the first dose of G-CSF for mobilization.
- Patients previously treated with Plerixafor
- Patients mobilised with chemotherapy other than cyclophosphamide 2 et 4 gr/m2
Other illness
- Clinical active infectious hepatitis type A, B, C or HIV
- Psychiatric, addictive, or any disorder/disease which compromises ability to give truly informed consent for participation in this study and renders the patient at high risk from treatment complications or impairs the ability to comply with the study treatment and protocol.
Lab values
- Left ventricular ejection fraction \< 50%.
Age
- Age \< 18.
Other
- Relapse/refractory MM patients
- Non secretory MM
- Primary plasmacell leukemia.
- Inability to tolerate PBPC harvest.
- Peripheral venous access not possible.
- Patients mobilised with growth factors at a dose other than (5-10µg/kg)
Who the study is looking for
- Newly diagnosed transplant eligible MM patients
- Measurable disease as defined by the presence of M-protein in serum or urine, or abnormal free light chain ratio
- Eligible and planned for HDT and autologous haematopoietic stem cell transplantation
- ≥18 years of age
- Patients or their legally authorized representatives must provide written informed consent
- Mobilization performed with G-CSF 2-4 g/m2 of cyclophosphamide and Plerixafor On Demand if considered needed based on center policies
- Patients can be included in interventional clinical trials
- Karnofsky performance status ≥ 60%
- Total bilirubin \< 1.5 upper limit of normal (ULN)
- AST/SGOT and ALT/SGPT \< 2.5 upper limit of normal (ULN)
- Serum creatinine \< 2 upper limit of normal (ULN)
- WBC count ≥2.5x109/L
- ANC count ≥1.5x109/L
- Platelet count ≥75x109/L
- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
- Women are not breast feeding and not pregnant
- A negative pregnancy test is required for women in child-bearing age; patients must agree to use an adequate method of contraception whilst on study treatment and for 3 months following plerixafor treatment
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A.O.U Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.