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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406091
• Other study ID #: MOZOBL06877
• Status: Completed
• Start date: November 26, 2015
• Est. completion date: January 17, 2024

Study information

• Verified date: February 2024
• Source: Fondazione EMN Italy Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 17, 2024
• Est. primary completion date: January 19, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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-1a (SDF-1a), 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.

Locations

Country	Name	City	State
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione EMN Italy Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	% of patients having received plerixafor in the study population		3 years
Secondary	Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not		3 years
Secondary	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
Secondary	Total number of CD34+ cells collected per apheresis day		3 years
Secondary	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