Autologous Haematopoietic Stem Cell TransplantPhase 4NCT05087212
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients
A Phase 4 study testing plerixafor + G-CSF in people with Autologous Haematopoietic Stem Cell Transplant, run by Sanofi at 1 site in China.
Trial summary
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autologous Haematopoietic Stem Cell Transplant
- What is being tested?
- plerixafor + G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2021to 30 Dec 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be with biopsy-confirmed diagnosis of multiple myeloma before the first mobilization, in first or second complete or partial remission
- The patient is eligible for autologous transplantation and treatment with an autologous peripheral Hematopoietic stem cell (HSC) transplant is planned
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment
- Has an actual body weight <175% of their ideal body weight (IBW)
- In agreement to use an approved form of contraception if of childbearing potential
Who cannot join
- If they had a comorbid condition which, in the view of the investigators, rendered the patient at high risk from treatment complications
- Active brain metastases or myelomatous meningitis
- Abnormal Electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
- Active infection requiring antibiotic treatment
- Fever (temperature > 38°C)
- Positive pregnancy test in female patients
Show all 28Show fewer
- Lactating females
- Had prior autologous or allogeneic transplantation
- Received bone-seeking radionuclides
- Received >6 cycles of induction therapy with lenalidomide
- Received >2 cycles of alkylating agent combinations
- Received more than 2 regimens of alkylating agent combinations
- Were less than 6 weeks off 1,3-bis(2-chloroethyl)-1- nitrosourea (BCNU) before first dose of G-CSF
- Were less than 4 weeks off last cycle of chemotherapy before first dose of G-CSF
- Failed previous hematopoietic stem cell collections or collection attempts
- Received radiation therapy to more than or equal to 50% of the pelvis
- Received specified treatment within specified duration.
- Patients whose apheresis product were to be further selected and purified
- Has received a live vaccine within 30 days of the planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted
- Had previously received experimental therapy within 4 weeks of enrolling or currently enrolled in another experimental protocol
- White blood cell (WBC) count, Absolute neutrophil count (ANC)PLT count, estimated creatinine clearance, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin should meet protocol requirements
- Positive test for HIV, active Hepatitis B (HBV), or active Hepatitis C (HCV) within 30 days prior to the first dose of IMP
- Has active central nervous system involvement
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- Participants are dependent on the Sponsor or Investigator
- Any specific situation during study implementation/course that may rise ethics considerations
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Open Label, Interventional Study Assessing the Mobilization Efficacy and Safety of Plerixafor in Combination With G- CSF in Multiple Myeloma Patients for Autologous Transplantation
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
Read the detailed description
The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier
- Being tested
- plerixafor + G-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plerixafor + G-CSFDrug
subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| plerixafor | Experimental | Participants will receive the first dose of plerixafor by subcutaneous (SC) injection on the evening of Day 4 (10 to 11 hours (± 1 hour) prior to the start of next day's apheresis). For a maximum of 4 days, patients will continue to receive daily plerixafor in the evening, followed by a morning dose of G-CSF and apheresis for up to a maximum of 4 apheresis or until ≥ 6×106 Cluster of differentiation 34 (CD34) + cells/kg were collected. Receives: Drug: plerixafor + G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days
Measured: Day 5 to Day 6
Secondary outcomes (6)
the proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 4 or fewer apheresis days
Measured: Day 5 to Day 8
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 2 or fewer apheresis days
Measured: Day 5 to Day 6
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 4 or fewer apheresis days
Measured: Day 5 to Day 8
the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg
Measured: Day 5 to Day 8
Peripheral Blood CD34+ count from Day 4 to Day 5 with the venous samples for Fluorescent activated cell sorting analysis obtained on the morning of Day 4 prior to administration of G-CSF and morning of Day 5 prior to administration of G-CSF
Measured: Day 4 to Day 5
Number of participants with Adverse events and Serious adverse events
Measured: Baseline to Day 30 (+7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start22 Oct 2021
- Primary completion6 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Haematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087212
- Sponsor's protocol ID
- LPS16586
- Other IDs
- U1111-1266-4898
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Interventional Study Assessing the Mobilization Efficacy and Safety of Plerixafor in Combination With G- CSF in Multiple Myeloma Patients for Autologous Transplantation
- ClinicalTrials.gov ID
- NCT05087212
- Acronym / sponsor ID
- LPS16586
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Oct 2021 (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.
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
Detailed description
The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plerixafor | Experimental | Drug: plerixafor + G-CSFParticipants will receive the first dose of plerixafor by subcutaneous (SC) injection on the evening of Day 4 (10 to 11 hours (± 1 hour) prior to the start of next day's apheresis). For a maximum of 4 days, patients will continue to receive daily plerixafor in the evening, followed by a morning dose of G-CSF and apheresis for up to a maximum of 4 apheresis or until ≥ 6×106 Cluster of differentiation 34 (CD34) + cells/kg were collected. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be with biopsy-confirmed diagnosis of multiple myeloma before the first mobilization, in first or second complete or partial remission
- The patient is eligible for autologous transplantation and treatment with an autologous peripheral Hematopoietic stem cell (HSC) transplant is planned
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment
- Has an actual body weight <175% of their ideal body weight (IBW)
Key exclusion criteria (28 listed)
- If they had a comorbid condition which, in the view of the investigators, rendered the patient at high risk from treatment complications
- Active brain metastases or myelomatous meningitis
- Abnormal Electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
- Active infection requiring antibiotic treatment
- Fever (temperature > 38°C)
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 |
|---|---|---|
| plerixafor + G-CSFsubcutaneous (SC) injection | Drug | plerixafor |
Primary outcome
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
6 secondary outcomes
the proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg
Time frame: Day 5 to Day 8
Peripheral Blood CD34+ count from Day 4 to Day 5 with the venous samples for Fluorescent activated cell sorting analysis obtained on the morning of Day 4 prior to administration of G-CSF and morning of Day 5 prior to administration of G-CSF
Time frame: Day 4 to Day 5
Number of participants with Adverse events and Serious adverse events
Time frame: Baseline to Day 30 (+7 days)
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 22 Sep 2025.
- LPS16586 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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?
A Phase 4 study testing plerixafor + G-CSF in people with Autologous Haematopoietic Stem Cell Transplant, run by Sanofi at 1 site in China.
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 28 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 22 Sep 2025. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days (time frame: Day 5 to Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.