- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406091
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients: Prospective Product Registry
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Torino, Italy, 10126
- A.O.U. Città della Salute e della Scienza di Torino
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
300 eligible patients ≥18 years old diagnosed with MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant may be enrolled. Patients must meet all the inclusion criteria listed below within 7 days of first administration of cyclophosphamide in addition to signing an informed consent form.
A patient will be considered enrolled after he/she has met all eligibility criteria and has started the protocol treatment.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Relapse/refractory MM patients
- Non secretory MM
- Primary plasmacell leukemia.
- Age < 18.
- Prior allogeneic or autologous transplantation.
- Prior failed mobilization attempt.
- Inability to tolerate PBPC harvest.
- Peripheral venous access not possible.
- Pregnant or nursing women or patients unwilling to have adequate contraception up to 3 months after end of treatment with plerixafor
- Clinical active infectious hepatitis type A, B, C or HIV
- 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.
- Left ventricular ejection fraction < 50%.
- Splenectomised or splenic irradiation.
- 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.
- 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
- Patients mobilised with growth factors at a dose other than (5-10µg/kg)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Poor Mobilizer (PM) in Multiple Myeloma (MM) patients
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Plerixafor (AMD3100) is a selective, reversible inhibitor of the receptor chemokine (C-X-C motif) receptor 4 (CXCR4) and prevents binding of its cognate ligand stromal cell derived factor-1α (SDF-1α), also known as chemokine (C-X-C motif) ligand 12 (CXCL12) [3].
CXCR4 is a co-receptor, along with CD4, for the binding of human immunodeficiency virus, type 1 (HIV-1) to its receptor cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Assessment of success rate expressed as % of patients mobilizing ≥2x106 CD34+ cells/kg in maximum 3 apheresis and patient who achieves the optimal target of 4x106 CD34+ cells/kg up to 5 apheresis.
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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% of patients having received plerixafor in the study population
Time Frame: 3 years
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3 years
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Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not
Time Frame: 3 years
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3 years
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Evaluation of speed of mobilization using plerixafor, in terms of increase in number of circulating CD34+ cells from time 0 to 6-11 hours after the first dose of plerixafor.
Time Frame: 3 years
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3 years
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Total number of CD34+ cells collected per apheresis day
Time Frame: 3 years
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3 years
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Confirmation of factors predicting a poor mobilization: patients who experienced grade 3-4 haematological toxicity during induction, used lenalidomide as induction treatment, aged > 60 years old and experienced cytopenia at diagnosis.
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Plerixafor
Other Study ID Numbers
- MOZOBL06877
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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