A Randomized, Double-Blind, Phase 2 Trial Evaluating the Efficacy, Safety and Tolerability of Primary Cardioprotection with Dapagliflozin in Patients with Newly Diagnosed Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525418-67-00

Enrollment

418

Registered

2026-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Proportion of participants experiencing at least one adjudicated major adverse cardiovascular event (MACE) during the defined study observation period

Detailed description

Frequency and severity of AEs categorized according to Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, Type and incidence of changes in laboratory results, Time from randomization to first occurrence of MACE, Proportion of participants experiencing at least one of individual adjudicated MACE during the defined study observation period, Time from randomization to first occurrence of individual MACE component, Cumulative incidence of MACE, Cumulative incidence of individual MACE components, Change from baseline in global longitudinal strain (GLS), Change from baseline in LVEF, Change from baseline in cardiac biomarkers (NT-proBNP, troponin T)

Interventions

DRUGForxiga 10 mg film-coated tablets

DRUGplacebo for Forxiga 10mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants experiencing at least one adjudicated major adverse cardiovascular event (MACE) during the defined study observation period	—

Secondary

Measure	Time frame
Frequency and severity of AEs categorized according to Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, Type and incidence of changes in laboratory results, Time from randomization to first occurrence of MACE, Proportion of participants experiencing at least one of individual adjudicated MACE during the defined study observation period, Time from randomization to first occurrence of individual MACE component, Cumulative incidence of MACE, Cumulative incidence of individual MACE components, Change from baseline in global longitudinal strain (GLS), Change from baseline in LVEF, Change from baseline in cardiac biomarkers (NT-proBNP, troponin T)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 22, 2026