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

NCT03406091 | Completed

• 1 other identifier: MOZOBL06877
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

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.

  3 years

Secondary Outcomes (5)

• % of patients having received plerixafor in the study population

  3 years

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

  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.

  3 years

• Total number of CD34+ cells collected per apheresis day

  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.

  3 years

Study Arms (1)

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

Drug: Plerixafor

Interventions

Plerixafor DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Newly diagnosed transplant eligible MM patients
• Measurable disease as defined by the presence of M-protein in serum or urine, or abnormal free light chain ratio
• Eligible and planned for HDT and autologous haematopoietic stem cell transplantation
• ≥18 years of age
• Patients or their legally authorized representatives must provide written informed consent
• Mobilization performed with G-CSF 2-4 g/m2 of cyclophosphamide and Plerixafor On Demand if considered needed based on center policies
• Patients can be included in interventional clinical trials
• Karnofsky performance status ≥ 60%
• Total bilirubin \< 1.5 upper limit of normal (ULN)
• AST/SGOT and ALT/SGPT \< 2.5 upper limit of normal (ULN)
• Serum creatinine \< 2 upper limit of normal (ULN)
• WBC count ≥2.5x109/L
• ANC count ≥1.5x109/L
• Platelet count ≥75x109/L
• Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant

You may not qualify if:

• Relapse/refractory MM patients
• Non secretory MM
• Primary plasmacell leukemia.
• Age \< 18.
• Prior allogeneic or autologous transplantation.
• Prior failed mobilization attempt.
• Inability to tolerate PBPC harvest.
• Peripheral venous access not possible.
• Pregnant or nursing women or patients unwilling to have adequate contraception up to 3 months after end of treatment with plerixafor
• Clinical active infectious hepatitis type A, B, C or HIV
• 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.
• Left ventricular ejection fraction \< 50%.
• Splenectomised or splenic irradiation.
• 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.
• Treatment with G-CSF or other cytokine within 2 weeks prior to the first dose of G-CSF for mobilization.

Sponsors & Collaborators

• Fondazione EMN Italy Onlus: lead

Study Sites (1)

A.O.U. Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Related Publications (1)

• Mina R, Petrucci MT, Bonello F, Bongarzoni V, Saccardi R, Bertuglia G, Mengarelli A, Spadaro A, Lisi C, Curci P, Lemoli RM, Ballanti S, Floris R, Cupelli L, Tosi P, Olivieri A, Rota-Scalabrini D, Cangialosi C, Nozzoli C, Anaclerico B, Fazio F, Bruno B, Mancuso K, Corradini P, Milone G, Boccadoro M. A prospective, multicenter study on hematopoietic stemcell mobilization with cyclophosphamide plus granulocyte colony-stimulating factor and 'on-demand' plerixafor in multiple myeloma patients treated with novel agents. Haematologica. 2024 May 1;109(5):1525-1534. doi: 10.3324/haematol.2023.284023.

  PMID: 37981892 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: November 26, 2015
• Primary Completion: January 19, 2021
• Study Completion: January 17, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)