AuthorisedTherapeutic exploratory (Phase II)Interventional

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

Multiple myeloma is a type of bone marrow cancer. Standard care often involves intensive chemotherapy followed by a stem cell transplant using your own cells. While this treatment works well against cancer, it can sometimes put stress on the heart. This trial investigates whether a medication called dapagliflozin (brand name Forxiga) can shield the heart from harm. Dapagliflozin is already widely used for heart failure and kidney problems. Researchers want to know if giving it before and during transplant protects heart function. Participants are randomly chosen to take either dapagliflozin (10 mg) or an identical dummy tablet (placebo) once daily. Doctors will monitor heart health closely using blood tests and heart scans. The main goal is to see whether dapagliflozin lowers the chance of serious heart issues without interfering with cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Instytut Hematologii I Transfuzjologii

Enrolment target

418

Start

21 Aug 2026

Multiple Myeloma

What is this study about?

Multiple myeloma is a cancer that affects plasma cells inside the bone marrow. A key part of treatment for many newly diagnosed patients is an autologous stem cell transplant. This involves collecting your own healthy blood-forming cells, giving high-dose chemotherapy to clear cancer cells, and then returning your stem cells back into your body to help your bone marrow recover.

Although stem cell transplants are very effective, the high-dose treatments and the transplant process itself can put temporary or lasting strain on your cardiovascular system. Doctors want to find better ways to safeguard the heart during this critical window of treatment so patients recover as smoothly as possible.

Dapagliflozin is an approved medication originally developed for type 2 diabetes that has proven very helpful in protecting the heart and kidneys in other conditions. In this Phase 2 study, doctors want to find out if taking dapagliflozin can act as a shield for the heart during a stem cell transplant. Because this is a randomised, double-blind trial, half the participants will take dapagliflozin and the other half will take a dummy pill (placebo), allowing researchers to clearly see if the medication makes a real difference.

Key takeaways

Tests whether the tablet dapagliflozin can protect the heart during a stem cell transplant for multiple myeloma.
Designed for newly diagnosed adults aged 18 and older preparing for an autologous stem cell transplant.
Participants take one tablet daily, receiving either dapagliflozin or an inactive placebo.
Heart health will be closely tracked using blood tests and ultrasound scans.
Taking part is voluntary and runs alongside your normal cancer care.

Who may be eligible?

This trial is open to adults aged 18 and over who have been newly diagnosed with multiple myeloma and are scheduled to undergo an autologous stem cell transplant as part of their planned cancer care.

Both men and women can join. Because the study focuses on preventing heart strain during transplant, participants must be well enough to undergo the transplant procedure itself.

Your hospital care team will check your medical history, kidney function, and overall health to make sure that taking part and using dapagliflozin is safe for you. If you have certain medical conditions or take medicines that clash with the trial drug, you might not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been newly diagnosed with multiple myeloma.
I am currently scheduled to have an autologous stem cell transplant.
I am able and willing to swallow a daily tablet.
I am happy to attend routine follow-up visits and heart checks.

Answer every question to see your result.

What does participation involve?

If you decide to join, you will be assigned by chance (like flipping a coin) to receive either dapagliflozin 10 mg or an identical dummy pill (placebo) once a day. Neither you nor your doctor will know which tablet you are taking, which keeps the results completely fair.

You will take your assigned tablet alongside your standard myeloma treatments and transplant care. Throughout the study, you will have regular hospital visits. These will include routine blood tests to look for heart strain markers (such as troponin and NT-proBNP), as well as heart ultrasound scans (echocardiograms) to measure how well your heart pumps.

Most tests are timed to fit around your usual transplant appointments to keep extra hospital visits to a minimum. The study team will track your health throughout your transplant recovery period to see how well you tolerate the medicine.

Potential risks and benefits

A potential benefit is that you will receive very thorough and regular heart checks throughout your transplant. If dapagliflozin works as hoped, it might help protect your heart, although this cannot be guaranteed. The main risks involve possible side effects of dapagliflozin, such as urinary tract infections, thrush, mild dizziness, or low blood pressure. There is also a 50% chance you receive the placebo, which contains no active medicine. Joining the trial is entirely your choice, and you can change your mind and stop at any time without your standard cancer care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is dapagliflozin?

Dapagliflozin (also known as Forxiga) is a prescription tablet already used in the NHS to treat type 2 diabetes, heart failure, and chronic kidney disease. This study is testing whether it can also protect hearts during cancer care.

Will taking part delay my stem cell transplant?

No. The study is designed to run alongside your planned stem cell transplant, so your cancer treatment should go ahead on schedule.

Why is a placebo (dummy pill) used?

Using an identical dummy pill helps researchers fairly compare results and prove whether any benefits or side effects are truly caused by dapagliflozin rather than chance.

Can I choose whether to receive the real drug or the dummy pill?

No. A computer assigns you to a group completely by chance. Neither you nor your hospital team can choose or know which pill you receive.

What happens if I decide to leave the trial?

You are free to leave at any time. If you withdraw, you will continue to receive the best standard care for your multiple myeloma, and your relationship with your medical team will not change.