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CompletedNCT03406091Updated Feb 20, 2024

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

An observational study in Multiple Myeloma, sponsored by Fondazione EMN Italy Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Fondazione EMN Italy Onlus · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Poor Mobilizer (PM) in Multiple Myeloma (MM) patients

    Drug: Plerixafor

Interventions

  • DrugPlerixafor

    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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. % of patients having received plerixafor in the study population

    Time frame: 3 years

  2. Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not

    Time frame: 3 years

  3. 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

  4. Total number of CD34+ cells collected per apheresis day

    Time frame: 3 years

  5. 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

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Study locations

1 site
  • A.O.U. Città della Salute e della Scienza di Torino
    Torino, 10126, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406091
Lead sponsor
Fondazione EMN Italy Onlus
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Nov 26, 2015
Primary completion
Jan 19, 2021
Completion
Jan 17, 2024
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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