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Dapagliflozin for Primary Cardioprotection in Newly Diagnosed Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation – A Randomized Phase 2 Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with Multiple Myeloma, a cancer of the blood‑forming cells, who are scheduled to receive autologous hematopoietic stem cell transplantation, a treatment that uses the patient’s own stem cells after high‑dose chemotherapy. The medication being tested is dapagliflozin, given in tablet form, and it is compared with a matching inactive tablet (placebo) to see if it can help protect the heart during this intensive therapy.

The purpose of the trial is to find out whether major adverse cardiovascular event rates are lower in patients who receive the study drug. Participants are randomly assigned to receive either the active drug or placebo, and neither the participants nor the doctors know which one is being taken (double‑blind). The medication is taken once daily, starting before the transplant and continuing for several months, with regular clinic visits for safety checks, blood tests, and heart imaging. Simple explanations are provided for any technical terms: a major adverse cardiovascular event includes serious heart problems such as heart attack or stroke; global longitudinal strain and LVEF are ways doctors measure how well the heart muscle moves and pumps; NT-proBNP and troponin T are blood markers that can indicate heart stress or damage.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After joining the study you are randomly assigned to receive either dapagliflozin or a matching placebo. the assignment is unknown to you and the study staff (double‑blind).

  2. Step 2

    Baseline assessments

    Before starting the study medication you undergo a series of baseline tests that include a cardiac evaluation, blood tests, and other routine examinations to record your health status at the start of the trial.

  3. Step 3

    Start of study medication

    You begin taking one 10 mg film‑coated tablet of the assigned product (either dapagliflozin or the placebo) by mouth each day as directed by the study team.

    The medication is continued daily for the duration of the trial observation period.

  4. Step 4

    Autologous hematopoietic stem cell transplantation

    While you are receiving the study medication you undergo autologous hematopoietic stem cell transplantation (auto‑hsct), the standard procedure for newly diagnosed multiple myeloma.

  5. Step 5

    Regular follow‑up visits

    Throughout the study you attend scheduled visits where the study team checks for any side effects, repeats cardiac assessments, and performs laboratory tests.

    Any adverse events are recorded and evaluated according to standardized criteria.

  6. Step 6

    Continuation of medication

    You keep taking the daily tablet (dapagliflozin or placebo) until the end of the defined observation period, unless a serious safety issue requires discontinuation.

  7. Step 7

    Final assessment

    At the conclusion of the study you undergo a final set of evaluations that include cardiac testing and laboratory analysis to determine the overall outcome of the trial.

Who can join the trial?

8 criteria

  • Must agree to take part in the study after understanding what it involves (this is called informed consent).
  • Both men and women are allowed to join.
  • Must be 18 years old or older when signing the consent form.
  • Must have a confirmed diagnosis of multiple myeloma (a type of blood cancer) that meets standard medical guidelines.
  • Must have an ECOG Performance Status score of 0, 1, or 2, meaning you are fully active or able to care for yourself but may have some limitations.
  • Must be considered suitable for high‑dose chemotherapy and for an autologous stem cell transplant (a procedure that uses your own blood‑forming cells) according to local practice.
  • Must have healthy enough liver and kidney function based on blood tests: liver tests (bilirubin and ALT) must be within set limits, and kidney function measured as eGFR must be greater than 25 ml/min/1.73 m².
  • If you can become pregnant, you must agree to use a highly effective birth‑control method during the study and for 28 days after the last treatment.

Who cannot join the trial?

21 criteria

  • History of another active cancer or current cancer treatment (other than multiple myeloma) that could affect study results.
  • Known involvement of the brain or spinal cord (central nervous system) by myeloma.
  • Serious brain conditions such as epilepsy (seizures), weakness (paresis), trouble speaking (aphasia), stroke, severe head injury, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis.
  • Major surgery performed within the 30 days before randomization.
  • Pregnancy or breastfeeding.
  • Allergy (hypersensitivity) to the study drug or any of its inactive ingredients (excipients).
  • Any prior anti‑cancer treatment for multiple myeloma before entering the study.
  • Significant other illnesses that would make the treatment unsafe or participation unsuitable.
  • Systemic light‑chain amyloidosis affecting organs such as the heart, kidneys, liver, stomach/intestines, or nerves that control automatic functions.
  • Diagnosis of plasma cell leukemia.
  • Any reason to avoid using flozins (SGLT2 inhibitors) according to the drug’s official guidance.
  • Use of any flozin (SGLT2 inhibitor) medication within the last three months.
  • Having type 1 diabetes mellitus.
  • Specific heart‑related conditions:
    • Heart failure diagnosed before multiple myeloma.
    • Left‑ventricular ejection fraction (LVEF) less than 50% at baseline.
    • Heart attack (myocardial infarction) or stroke within 90 days before enrollment.
    • Low systolic blood pressure (below 95 mmHg) measured repeatedly during screening.
    • Uncontrolled high blood pressure (above 180/110 mmHg) despite multiple medicines.
    • Permanent or chronic atrial fibrillation or atrial flutter (irregular heart rhythm), unless a pacemaker keeps a normal rhythm.
    • Active, severe bacterial, viral, or fungal infection at the time of eligibility assessment.
    • Active mental illness that prevents the patient from cooperating.
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Investigated drugs

Forxiga is an oral medication that belongs to a class of drugs called SGLT2 inhibitors. It works by helping the kidneys remove extra sugar from the body through the urine, which can also have beneficial effects on the heart and blood vessels. In this trial, Forxiga is being given to patients with newly diagnosed multiple myeloma who are preparing for an autologous stem cell transplant. The purpose is to find out whether taking Forxiga can lower the chance of heart‑related problems, such as heart attacks or heart failure, that sometimes occur during or after the transplant procedure.

What is already known about the treatment

Forxiga 10 mg film-coated tablets - This medication is taken by mouth as a film‑coated tablet containing 10 mg of dapagliflozin. It is an approved drug for type 2 diabetes and is also used to help protect the heart and kidneys in people with heart failure or chronic kidney disease, with many studies supporting its safety and benefits. The main idea is to block a protein called SGLT2 in the kidneys, which stops the body from re‑absorbing sugar, so more sugar leaves the body in urine, lowering blood sugar and reducing strain on the heart and kidneys. It belongs to the class of medicines known as SGLT2 inhibitors, a type of antidiabetic drug.

Investigated diseases

Multiple Myeloma - Multiple Myeloma is a blood cancer that originates from plasma cells in the bone marrow. It causes an abnormal buildup of these cells, which can displace normal blood‑forming cells. The disease often leads to bone damage, anemia and reduced immune function. As it progresses, the abnormal plasma cells may spread throughout the marrow and enter the bloodstream, increasing the level of abnormal protein in the blood. Advanced disease can affect organ function due to the excess protein and cellular infiltration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525418-67-00Protocol codeHEART-DAPA-MMEstimated enrolment418 patientsSponsorInstytut Hematologii I Transfuzjologii

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