Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Immune System Diseases

Blood and Lymph Conditions

Rare Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Paraproteinemias

AL Amyloidosis

Hypoglycemic Agents

All Drugs and Chemicals

Dapagliflozin

Sodium-Glucose Transporter 2 Inhibitors

Dapagliflozin 10mg orally, daily for 6 months

Christiane Houde

Jeffery Zonder, M.D.

Jeffery Zonder

Andrew Kin, M.D.

Aditi Sharma, M.D.

Joel Topf, M.D.

The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design.

Participants will be:

* screened for the trial via an online platform
* contacted by study personal to obtain electronic consent
* enrolled in the trial if eligible and consented
* contacted by study personal for further instructions and directions
* sent dapagliflozin oral medication (supplied by the site pharmacy)
* followed up regularly with the study team via telemedicine or other online avenues
* monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months
* continue treatment for 6 months

1. Participants are recruited by one of the following methods:

   1. Self-referral through the website
   2. Receiving recruitment materials from their provider.
2. Participant visits the prescreening website.

   1. High level prescreening questions are answered by the participant.
   2. If appropriate based on answers to the questions, the participant may provide their contact information for follow up by the study team.
3. Study team contacts potential participants to review the study and explain next steps
4. Participant is provided with the link and password to view the video and sign the consent via Adobe Sign
5. An investigator will meet virtually with the participant to obtain medical history information, concomitant medications, and performance status (screening visit)
6. Once the participant passes screening in step 5, an order will be sent to the participant for the remaining screening labs to be done at a local laboratory that is covered by their insurance
7. The lab will fax results to the site
8. After review of eligibility and the study team will proceed with enrolling the participant if appropriate
9. The participant will proceed to the baseline visit (telehealth for any portion that can be done via phone/video and order for lab tests as previously described) if needed to comply with the protocol calendar/window.
10. The participant is approved to begin dosing by the investigator
11. The site will dispense via mail the following:

    1. 4 month's supply of Dapagliflozin
    2. A self-addressed envelope for return of the diary and pill bottles at the end of the dosing period
    3. A weighing scale (if required)
12. Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary
13. If clinically indicated, labs will be ordered and run more frequently to assess for toxicity.
14. Visits 3, 4, and 5 will be conducted in the same manner as described above.
15. All pill bottles and diaries (if paper version is used) will be returned via the provided envelope

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

A patient's status will be recorded as 'yes' if any of the following three events occur at any time during the 6 months of study therapy: a sustained ≥50% decline in estimated glomerular filtration rate (eGFR); the onset of dialysis-requiring end- stage renal disease (ESRD); or death from a renal disease-related or cardiovascular cause. Otherwise, the status will be marked as 'no'.

The onset of ESRD in patients with Pavia Renal Stage II or III involvement will be recorded as binary (yes vs. no).

A patient will be considered to have achieved the desired urine protein reduction if a 30% reduction in 24-hour albuminuria occurs at any point during the six-month period from the initiation of dapagliflozin therapy. The proportion of patients achieving this reduction will be calculated as the ratio of the total number of patients who experienced the reduction to the total number of evaluable patients.

The completion rate of tele-visits, including post-trial feedback, will be calculated as the ratio of completed tele-visits to scheduled tele-visits.

Jeffrey Zonder

Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)	NCT06420167	Renal AL Amyloi...	Dapagliflozin	18 Years -	Barbara Ann Karmanos Cancer Institute
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)	NCT06420167	Renal AL Amyloi...	Dapagliflozin	18 Years -	Barbara Ann Karmanos Cancer Institute
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)	NCT06420167	Renal AL Amyloi...	Dapagliflozin	18 Years -	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for renal al amyloidosis