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

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ClinicalTrials.gov Identifier: NCT05087212
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Autologous Haematopoietic Stem Cell Transplant Drug: plerixafor + G-CSF Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2021
Estimated Primary Completion Date : December 10, 2022
Estimated Study Completion Date : February 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Plerixafor

Arm Intervention/treatment
Experimental: plerixafor
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
subcutaneous (SC) injection




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg [ Time Frame: Day 5 to Day 8 ]
  5. 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 ]
  6. Number of participants with Adverse events and Serious adverse events [ Time Frame: Baseline to Day 30 (+7 days) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • At least 4 weeks since last cycle of chemotherapy -- Eastern Cooperative Oncology Group performance status of 0 or 1 -- Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment -- In agreement to use an approved form of contraception if of childbearing potential -

Exclusion Criteria:

  • If they had a comorbid condition which, in the view of the investigators, rendered the patient at high risk from treatment complications
  • A residual acute medical condition resulting from prior chemotherapy - Had prior autologous or allogeneic transplantation
  • Received bone-seeking radionuclides
  • 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
  • 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 - 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 requirement
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087212


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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China
Investigational Site Recruiting
China, China
Sponsors and Collaborators
Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05087212    
Other Study ID Numbers: LPS16586
U1111-1266-4898 ( Registry Identifier: ICTRP )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 29, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Plerixafor
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents