Observational Study to Evaluate Hematopoietic Progenitor Cell Mobilization in Patients With Newly Diagnosed Multiple Myeloma
A Prospective, Multicenter, Observational Study to Evaluate Hematopoietic Progenitor Cell Mobilization in Patients With Newly Diagnosed Multiple Myeloma
1 other identifier
observational
750
1 country
1
Brief Summary
Prospective, multicenter, observational registry of myeloma patients undergoing hematopoietic progenitor cell mobilization for upfront autologous transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedMarch 28, 2023
March 1, 2023
4.3 years
June 12, 2017
March 25, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Total CD34+ cell yield on the first apheresis
Evaluate efficacy of PBPC mobilization and collection in myeloma patients undergoing cytokine-only vs. chemomobilization vs. plerixafor-based mobilization efficacy parameters including total CD34+ cell yield on the first apheresis (per kg patient weight)
6/1/17-1/1/19
CD34+ cell yield
Evaluate efficacy parameters including total CD34+ cell yield
6/1/17-1/1/19
Number of apheresis sessions
Evaluate efficacy parameters including total number of apheresis sessions (comparison of means across groups)
6/1/17-1/1/19
Mobilization failure rates
Evaluate efficacy parameters including mobilization failure rates (defined as failure to collect ≥2 million CD34+ cells per kg patient weight)
6/1/17-1/1/19
Study Arms (3)
Cytokine alone or JIT plerixafor based mobilization
Routine plerixafor based mobilization
Chemomobilization
Interventions
Autologous hematopoietic cell transplant
Eligibility Criteria
Patients will be reported consecutively from CIBMTR centers with comprehensive report form (CRF) level reporting. The centers will be chosen based on MM autoHCT volume, center practices for mobilization in order to ensure a fair distribution of various mobilization strategies. A total of 750 patients will be enrolled prospectively from approximately 20 selected centers.
You may qualify if:
- Myeloma patients ages 18-70 years.
- Undergoing upfront autoHCT (≤12 months from start of initial therapy for myeloma).
You may not qualify if:
- Patients with light chain (AL) amyloidosis or myeloma with associated AL amyloidosis.
- POEMS syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
Center for International Blood and Marrow Transplant Research
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 27, 2017
Study Start
June 1, 2017
Primary Completion
September 29, 2021
Study Completion
October 31, 2022
Last Updated
March 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
No IPD to be shared