Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients

February 19, 2024 updated by: Fondazione EMN Italy Onlus

Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients: Prospective Product Registry

The study is an italian multicentric and will be conducted in 20 centers. The aim of this study is to evaluate poor mobilizer (PM) rate in newly diagnosed MM patients who are mobilized with cyclophosphamide and G-CSF and plerixafor on demand.

Plerixafor is a specific reversible inhibitor of the chemokine receptor CXCR4 and prevents the binding of its ligand stromal cell derived factor SDF-1α also known as CXCL12, thereby releasing hematopoietic stem cells into the circulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

300 eligible patients ≥18 years old diagnosed with MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant may be enrolled. Patients must meet all the inclusion criteria listed below within 7 days of first administration of cyclophosphamide in addition to signing an informed consent form.

A patient will be considered enrolled after he/she has met all eligibility criteria and has started the protocol treatment.

Description

Inclusion Criteria:

  1. Newly diagnosed transplant eligible MM patients
  2. Measurable disease as defined by the presence of M-protein in serum or urine, or abnormal free light chain ratio
  3. Eligible and planned for HDT and autologous haematopoietic stem cell transplantation
  4. ≥18 years of age
  5. Patients or their legally authorized representatives must provide written informed consent
  6. Mobilization performed with G-CSF 2-4 g/m2 of cyclophosphamide and Plerixafor On Demand if considered needed based on center policies
  7. Patients can be included in interventional clinical trials
  8. Karnofsky performance status ≥ 60%
  9. Total bilirubin < 1.5 upper limit of normal (ULN)
  10. AST/SGOT and ALT/SGPT < 2.5 upper limit of normal (ULN)
  11. Serum creatinine < 2 upper limit of normal (ULN)
  12. WBC count ≥2.5x109/L
  13. ANC count ≥1.5x109/L
  14. Platelet count ≥75x109/L
  15. Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
  16. Women are not breast feeding and not pregnant
  17. A negative pregnancy test is required for women in child-bearing age; patients must agree to use an adequate method of contraception whilst on study treatment and for 3 months following plerixafor treatment

Exclusion Criteria:

  1. Relapse/refractory MM patients
  2. Non secretory MM
  3. Primary plasmacell leukemia.
  4. Age < 18.
  5. Prior allogeneic or autologous transplantation.
  6. Prior failed mobilization attempt.
  7. Inability to tolerate PBPC harvest.
  8. Peripheral venous access not possible.
  9. Pregnant or nursing women or patients unwilling to have adequate contraception up to 3 months after end of treatment with plerixafor
  10. Clinical active infectious hepatitis type A, B, C or HIV
  11. Acute infection (febrile, i.e. temperature > 38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
  12. Left ventricular ejection fraction < 50%.
  13. Splenectomised or splenic irradiation.
  14. Psychiatric, addictive, or any disorder/disease which compromises ability to give truly informed consent for participation in this study and renders the patient at high risk from treatment complications or impairs the ability to comply with the study treatment and protocol.
  15. Treatment with G-CSF or other cytokine within 2 weeks prior to the first dose of G-CSF for mobilization.
  16. Patients previously treated with Plerixafor
  17. Patients mobilised with chemotherapy other than cyclophosphamide 2 et 4 gr/m2
  18. Patients mobilised with growth factors at a dose other than (5-10µg/kg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Poor Mobilizer (PM) in Multiple Myeloma (MM) patients
Plerixafor (AMD3100) is a selective, reversible inhibitor of the receptor chemokine (C-X-C motif) receptor 4 (CXCR4) and prevents binding of its cognate ligand stromal cell derived factor-1α (SDF-1α), also known as chemokine (C-X-C motif) ligand 12 (CXCL12) [3]. CXCR4 is a co-receptor, along with CD4, for the binding of human immunodeficiency virus, type 1 (HIV-1) to its receptor cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of success rate expressed as % of patients mobilizing ≥2x106 CD34+ cells/kg in maximum 3 apheresis and patient who achieves the optimal target of 4x106 CD34+ cells/kg up to 5 apheresis.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
% of patients having received plerixafor in the study population
Time Frame: 3 years
3 years
Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not
Time Frame: 3 years
3 years
Evaluation of speed of mobilization using plerixafor, in terms of increase in number of circulating CD34+ cells from time 0 to 6-11 hours after the first dose of plerixafor.
Time Frame: 3 years
3 years
Total number of CD34+ cells collected per apheresis day
Time Frame: 3 years
3 years
Confirmation of factors predicting a poor mobilization: patients who experienced grade 3-4 haematological toxicity during induction, used lenalidomide as induction treatment, aged > 60 years old and experienced cytopenia at diagnosis.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2015

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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