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

NCT ID: NCT03406091

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-26
• Study Completion Date: 2024-01-17

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Plerixafor

Intervention Type: 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.

Interventions

Plerixafor

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione EMN Italy Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Torino, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37981892 (View on PubMed)

Other Identifiers

MOZOBL06877

Identifier Type: -

Identifier Source: org_study_id