Multiple MyelomaNCT03406091
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients
An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Plerixafor
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2015to 17 Jan 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- Relapse/refractory MM patients
- Non secretory MM
- Primary plasmacell leukemia.
- Age < 18.
- Prior allogeneic or autologous transplantation.
- Prior failed mobilization attempt.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Plerixafor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Poor Mobilizer (PM) in Multiple Myeloma (MM) patients | Not described Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
% of patients having received plerixafor in the study population
Measured: 3 years
Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not
Measured: 3 years
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.
Measured: 3 years
Total number of CD34+ cells collected per apheresis day
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start26 Nov 2015
- Primary completion19 Jan 2021
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406091
- Sponsor's protocol ID
- MOZOBL06877
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mina R, Petrucci MT, Bonello F, Bongarzoni V, Saccardi R, Bertuglia G, Mengarelli A, Spadaro A, Lisi C, Curci P, Lemoli RM, Ballanti S, Floris R, Cupelli L, Tosi P, Olivieri A, Rota-Scalabrini D, Cangialosi C, Nozzoli C, Anaclerico B, Fazio F, Bruno B, Mancuso K, Corradini P, Milone G, Boccadoro M. A prospective, multicenter study on hematopoietic stemcell mobilization with cyclophosphamide plus granulocyte colony-stimulating factor and 'on-demand' plerixafor in multiple myeloma patients treated with novel agents. Haematologica. 2024 May 1;109(5):1525-1534. doi: 10.3324/haematol.2023.284023.
PubMed 37981892
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients: Prospective Product Registry
- ClinicalTrials.gov ID
- NCT03406091
- Acronym / sponsor ID
- MOZOBL06877
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- 26 Nov 2015 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor Mobilizer (PM) in Multiple Myeloma (MM) patients | – | Drug: Plerixafor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (18 listed)
- Relapse/refractory MM patients
- Non secretory MM
- Primary plasmacell leukemia.
- Age < 18.
- Prior allogeneic or autologous transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforPlerixafor (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. | Drug | Poor Mobilizer (PM) in Multiple Myeloma (MM) patients |
Primary outcome
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
5 secondary outcomes
% of patients having received plerixafor in the study population
Time frame: 3 years
Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not
Time frame: 3 years
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
Total number of CD34+ cells collected per apheresis day
Time frame: 3 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 37981892Mina R, Petrucci MT, Bonello F, Bongarzoni V, Saccardi R, Bertuglia G, Mengarelli A, Spadaro A, Lisi C, Curci P, Lemoli RM, Ballanti S, Floris R, Cupelli L, Tosi P, Olivieri A, Rota-Scalabrini D, Cangialosi C, Nozzoli C, Anaclerico B, Fazio F, Bruno B, Mancuso K, Corradini P, Milone G, Boccadoro M. A prospective, multicenter study on hematopoietic stemcell mobilization with cyclophosphamide plus granulocyte colony-stimulating factor and 'on-demand' plerixafor in multiple myeloma patients treated with novel agents. Haematologica. 2024 May 1;109(5):1525-1534. doi: 10.3324/haematol.2023.284023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
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 17 inclusion and 18 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 20 Feb 2024. 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 Italy. 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.
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?
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). 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 NCT03406091, 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 20 Feb 2024.