Multiple Myeloma Clinical Trial

Isatuximab in Lung Transplant Recipients

Summary

The purpose of this study is to determine the safety and feasibility of adding treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >isatuximab to standard of care therapies in patients who will receive a lung transplant, but have significant antibodies against the donor (desensitization), or patients who have previously received a lung transplant and develop antibodies against the donor (antibody-mediated rejection, AMR). The study will compare the impact of isatuximab on the recurrence of antibodies after they have been removed from the blood by a process known as plasmapheresis that is standard of care for this condition. The use of isatuximab in lung transplant recipients is investigational, meaning it is not Food and Drug Administration (FDA) approved for use in lung transplant recipients. This study is a pilot study investigating the feasibility and safety of isatuximab in lung transplant patients. Isatuximab is an FDA approved drug indicated for the treatment of multiple myeloma. It may also be useful for transplant recipients with antibodies against the donor because it eliminates the cells that make antibodies.

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Full Description

This dual-arm pilot study will enroll approximately 6 patients undergoing lung transplantation at NYU Langone Health who are either receiving peri-transplant desensitization, or who are admitted for treatment of AMR. All patients will be treated with standard-of-care consisting of plasmaspheresis, IVIG, and rituximab. Additionally, the experimental agent, isatuximab, will be added to this treatment protocol. The patients will first receive 4 weekly doses of isatuximab, followed by 4 bi¬-weekly doses (total 8 doses given over 12 weeks). Patients will be followed with standard-of-care immunologic assessment consisting of weekly DSA assessment and flow cytometry crossmatch (only in the desensitization arm). Additionally, patients undergoing peri-transplant desensitization will have a bone marrow biopsy with pathologic examination and cell counts performed at the time of transplant and repeated at the 30-day bronchoscopy to assess for plasma cell elimination.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cohort A (Desensitization) Inclusion Criteria:

Age ≥ 18 years
Listed and will receive a lung transplant or multi-organ transplant involving a lung at NYU Langone Health that is deemed to require peri-transplant desensitization
Able and willing to provide informed consent
Pre-transplant DSA > 5,000 MFI in undiluted serum (measured as individual DSA MFI or as sum of multiple DSAs >1000 MFI in the undiluted serum)

Cohort B (AMR) Inclusion Criteria:

Age ≥ 18 years
Received a lung transplant or multi-organ transplant involving a lung at NYU Langone Health
Able and willing to provide informed consent
Allograft dysfunction in the setting of at least one of the following criteria:
Histopathology suggestive of AMR
Lung biopsy demonstrating C4d deposition
Positive DSA > 2,000 MFI (as individual DSA MFI)

Exclusion Criteria:

Prior or current treatment with rituximab within 6 months of isatuximab administration
Prior or current treatment with tocilizumab within 6 months of isatuximab administration
Contraindication to isatuximab due to intolerance or hypersensitivity
Pregnant or breastfeeding women
Known malignancy
Active infection without adequate treatment or source control
Known hepatitis B viral infection
Known HIV infection

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

6

Study ID:

NCT05862766

Recruitment Status:

Not yet recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States More Info
Tyler Lewis, PharmD
Contact
Luis Angel, MD
Principal Investigator

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Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

6

Study ID:

NCT05862766

Recruitment Status:

Not yet recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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