Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients

NCT05087212 | Completed Phase 4

• 2 other identifiers: LPS16586U1111-1266-4898
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autologous Haematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days

  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

  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

  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

  Day 5 to Day 8

• the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg

  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

  Day 4 to Day 5

Study Arms (1)

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.

Drug: plerixafor + G-CSF

Interventions

plerixafor + G-CSF DRUG

subcutaneous (SC) injection

plerixafor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Active infection requiring antibiotic treatment
• Fever (temperature \> 38°C)
• Positive pregnancy test in female patients
• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Sites

China, China

Location

Related Links

• LPS16586 Plain Language Results Summary

MeSH Terms

Interventions

plerixafor; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 21, 2021
• Study Start: October 22, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 30, 2022
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)