AuthorisedTherapeutic exploratory (Phase II)Interventional

Multicenter, open label, phase II clinical trial evaluating the combination of elranatamab with mezigdomide and dexamethasone in patients with relapsed/refractory multiple myeloma

Multiple myeloma is a type of blood cancer that develops in the bone marrow. Although treatments have improved, the cancer often returns (relapses) or stops responding to medication (refractory). This phase 2 trial tests a new combination of three drugs: elranatamab, mezigdomide, and dexamethasone. Elranatamab helps the body's immune system target and attack myeloma cells. Mezigdomide is a newer oral drug designed to destroy specific proteins that help cancer cells grow, and dexamethasone is a common steroid that supports cancer therapies. The main aim of the study is to find out if taking these medicines together can reduce cancer cells to undetectable levels in the bone marrow—a state known as 'minimal residual disease negativity'. The study will also track how long this response lasts and monitor any side effects to ensure the treatment is as safe as possible.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion PETHEMA

Enrolment target

Start

13 Oct 2026

Relapsed/refractory multiple myeloma

What is this study about?

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell made in the bone marrow. While initial treatments can work well, myeloma often returns over time or becomes resistant to standard therapies. When this happens, doctors need new, more powerful combinations of medicines to bring the disease back under control.

This trial is testing a combination of three medicines: elranatamab (Elrexfio), mezigdomide, and dexamethasone. Elranatamab is an immunotherapy given as an injection that acts like a bridge, connecting your own immune cells directly to cancer cells so your body can fight them. Mezigdomide is an oral capsule that breaks down proteins cancer cells need to survive. Dexamethasone is a familiar steroid tablet often used to make myeloma treatments work better.

Doctors want to find out how deeply this combination can clear the cancer. In particular, they are measuring something called 'minimal residual disease' (MRD). Being MRD-negative means that even with extremely sensitive tests, doctors cannot find a single myeloma cell among 100,000 bone marrow cells. Achieving this deep level of response often helps patients stay in remission for much longer.

Because this is an open-label phase 2 study, every person who joins will receive the study drugs; there is no dummy drug (placebo). By testing how well the combination works and watching for any side effects, researchers hope to provide a vital new treatment option for people with difficult-to-treat myeloma.

Key takeaways

Tests a three-drug combination (elranatamab, mezigdomide, and dexamethasone) for multiple myeloma.
Aimed at adults whose cancer has returned or stopped responding to past treatments.
Every participant receives the active medicines; there is no placebo.
The main goal is to clear cancer cells from the bone marrow to undetectable levels.
You can withdraw from the trial at any point without losing your standard care.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with relapsed or refractory multiple myeloma. This means your cancer has come back after earlier treatments, or your previous medication has stopped keeping the disease under control.

To be considered, you will need to have had prior treatment for myeloma. Your hospital team will also check that your major organs—such as your heart, liver, and kidneys—are working well enough for you to safely receive these medicines.

You might not be eligible if you have certain active infections, significant heart problems, or if you are currently taking other cancer therapies that could interfere with the study medicines. Your doctor will carry out detailed blood tests and health checks to confirm whether this trial is safe and appropriate for you.

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 diagnosed with multiple myeloma.
My myeloma has returned (relapsed) or stopped responding to previous treatments.
I am well enough to attend regular hospital appointments for check-ups and injections.
I am willing to undergo blood tests and bone marrow samples as part of the study.

Answer every question to see your result.

What does participation involve?

Taking part involves receiving treatment in repeating cycles. Elranatamab is given as an injection just under the skin (subcutaneously), while mezigdomide and dexamethasone are taken as tablets by mouth at home on set days of each cycle.

You will need to visit the hospital regularly, particularly during the first few weeks, so the medical team can monitor you closely for any reactions. Visits will include blood tests, physical examinations, and occasional bone marrow samples to measure how well the treatment is clearing the cancer cells.

You will continue the treatment for as long as it is helping to control your myeloma and the side effects remain manageable. After you finish treatment, the study team will continue to check on your health and well-being every few months.

Potential risks and benefits

Taking part may help bring your myeloma into a deep remission, potentially clearing cancer cells that other treatments could not reach. You will also be monitored very closely by specialist doctors and nurses throughout. However, as with all cancer treatments, there is a risk of side effects. These can include a drop in your blood cell counts, a higher risk of infections, tiredness, or immune reactions such as fever. There is also no guarantee that the combination will work for everyone. Joining the trial is entirely your choice, and you are free to leave at any time without your regular NHS 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
Spain

Common questions

Will I receive a placebo (dummy treatment)?

No. This is an open-label trial, which means everyone who joins will receive the active study medications.

How are the medicines given?

Elranatamab is given as an injection under the skin at the clinic. Mezigdomide and dexamethasone are tablets that you swallow at home according to a specific schedule.

What does 'MRD negativity' mean?

MRD stands for minimal residual disease. Being MRD-negative means that specialised lab tests cannot find any cancer cells in your bone marrow, showing the treatment has cleared the cancer to very deep levels.

Do I have to pay to take part?

No. The study medications and any extra tests required for the clinical trial are provided free of charge.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can choose to stop at any time, and your medical team will help you switch to standard care options.