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DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

Cancer Categories

Hematologic (Blood Cancers)

Karmanos Trial ID

2023-074

NCT ID

NCT06420167

Age Group

Adult

Scope

Local

Phase

Phase II

Principal Investigator

Jeffrey
Zonder, M.D.
Oncology - Hematology, Oncology - Medical View Profile

Objective:

Primary Objective:

To evaluate the efficacy of dapagliflozin in reducing proteinuria in patients with renal AL amyloidosis.

Secondary Objective:

Assess the feasibility of implementing the DCT approach in terms of protocol adherence and patient satisfaction.

Safety Objective:

To evaluate the safety and tolerability of dapagliflozin in renal AL amyloidosis patients.

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Eligibility

Eligibility

Inclusion Criteria:

Provision of signed and dated informed consent form.
Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile/web applications for study purposes.
Age ≥18 years.
Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of >1.0 g/day proteinuria without any other identifiable cause.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician.
Residence in the state of Michigan.

Exclusion Criteria:

Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for <6 months prior to enrollment.
Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past.
Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding.
Known allergic reactions to components of the dapagliflozin.
Treatment requiring type 1 or type 2 diabetes mellitus.
Baseline eGFR <25 mL/min/1.73m2.
Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy)
Current or previous use of any SGLT2i.
Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) <3 months prior to enrollment.

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

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