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Observational Study to Evaluate Hematopoietic Progenitor Cell Mobilization in Patients With Newly Diagnosed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200626
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Mehdi Hamadani, Medical College of Wisconsin

Brief Summary:
Prospective, multicenter, observational registry of myeloma patients undergoing hematopoietic progenitor cell mobilization for upfront autologous transplantation.

Condition or disease Intervention/treatment
Multiple Myeloma Bone Marrow Transplant Complications Procedure: Autologous hematopoietic cell transplant

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Observational Study to Evaluate Hematopoietic Progenitor Cell Mobilization in Patients With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 24, 2021
Estimated Study Completion Date : September 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Cytokine alone or JIT plerixafor based mobilization Procedure: Autologous hematopoietic cell transplant
Autologous hematopoietic cell transplant

Routine plerixafor based mobilization Procedure: Autologous hematopoietic cell transplant
Autologous hematopoietic cell transplant

Chemomobilization Procedure: Autologous hematopoietic cell transplant
Autologous hematopoietic cell transplant




Primary Outcome Measures :
  1. Total CD34+ cell yield on the first apheresis [ Time Frame: 6/1/17-1/1/19 ]
    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)

  2. CD34+ cell yield [ Time Frame: 6/1/17-1/1/19 ]
    Evaluate efficacy parameters including total CD34+ cell yield

  3. Number of apheresis sessions [ Time Frame: 6/1/17-1/1/19 ]
    Evaluate efficacy parameters including total number of apheresis sessions (comparison of means across groups)

  4. Mobilization failure rates [ Time Frame: 6/1/17-1/1/19 ]
    Evaluate efficacy parameters including mobilization failure rates (defined as failure to collect ≥2 million CD34+ cells per kg patient weight)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Myeloma patients ages 18-70 years.
  • Undergoing upfront autoHCT (≤12 months from start of initial therapy for myeloma).

Exclusion Criteria:

  • Patients with light chain (AL) amyloidosis or myeloma with associated AL amyloidosis.
  • POEMS syndrome

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): NCT03200626


Locations
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United States, Wisconsin
Center for International Blood and Marrow Transplant Research
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Genzyme, a Sanofi Company
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Responsible Party: Mehdi Hamadani, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03200626    
Other Study ID Numbers: SC15-04
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD to be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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