Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of elranatamab, mezigdomide and dexamethasone in patients with relapsed/refractory multiple myeloma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

Patients with relapsed/refractory multiple myeloma, a form of blood cancer that has returned after previous treatment or no longer responds, are being studied. The trial uses a combination of three medicines: elranatamab, which is given as a subcutaneous injection, mezigdomide, taken as an oral capsule, and dexamethasone, a steroid that can be taken by mouth or injection. These drugs work together to try to reduce cancer cells to very low levels.

The main aim of the study is to see how often patients reach MRD negativity, meaning that tests cannot detect any remaining cancer cells. To check this, a sensitive test called NGF is performed on samples from the BM. Responses are measured using the standards set by the IMWG criteria, including levels such as CR and PR. Participants will receive the medication on a regular schedule, attend routine clinic visits, and undergo blood work and occasional bone‑marrow sampling over several months, with follow‑up after treatment ends to monitor health and any possible AEs or SAEs. The study also records how long the disease stays under control, known as PFS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Evaluation

    After you join the study, you will undergo a series of baseline examinations that include blood tests, a bone‑marrow sample, and other assessments needed to document the status of your disease before treatment begins.

  2. Step 2

    Start of Combination Therapy

    On the first day of treatment you will begin the combination of three medicines:

    Mezigdomide 0.3 mg taken orally as a capsule;

    Elranatamab 76 mg administered by subcutaneous injection;

    And dexamethasone taken as directed by the study protocol.

    These three agents are given together to start the therapeutic cycle.

  3. Step 3

    Continuation of Treatment Cycles

    You will continue to receive the same regimen in each treatment cycle.

    If the study protocol allows and you tolerate the medication well, the dose of mezigdomide may be increased to 0.6 mg per capsule after a predefined number of cycles.

    The subcutaneous injection of elranatamab 76 mg and the prescribed dose of dexamethasone will be continued in every cycle unless a dose adjustment is required for safety reasons.

  4. Step 4

    Regular Monitoring and Assessments

    Throughout the treatment period you will have periodic blood tests, safety examinations, and repeat bone‑marrow samples.

    These bone‑marrow evaluations are performed to determine MRD negativity, which means no detectable disease at a sensitivity of 10‑5.

    All safety information, including any side effects, will be recorded at each visit.

  5. Step 5

    Completion of Treatment

    Treatment will end when the study protocol specifies, such as after a set number of cycles, if disease progression occurs, or if side effects become unacceptable.

    You will be informed of the exact stopping point by the study team.

  6. Step 6

    Post‑Treatment Follow‑Up

    After the last dose, you will continue to be monitored for at least four weeks.

    During this follow‑up period, additional safety assessments and laboratory tests will be performed to capture any late‑appearing effects.

Who can join the trial?

11 criteria

  • Willing and able to follow the visit schedule and follow all study instructions.
  • All previous treatment‑related side effects must be mild (≤ grade 1) as defined by the NCI‑CTCAE system, which is a standard way doctors grade the severity of side effects.
  • Must meet the study’s reproductive requirements, meaning you cannot be pregnant and must use effective birth control if applicable.
  • Must be able to understand what will be done in the study.
  • Must be at least 18 years old when signing the consent form.
  • Must have a confirmed diagnosis of multiple myeloma based on the IMWG criteria, a set of guidelines used by doctors to define this disease.
  • Must have relapsed multiple myeloma, meaning the cancer returned after previous treatment, and you must have had at least one prior line of antimyeloma therapy.
  • Must show disease progression during or after the last antimyeloma treatment.
  • Must have previously received a treatment that included the drug lenalidomide and be either intolerant (could not tolerate side effects) or refractory (the disease continued to grow while on the drug or within 60 days after stopping it).
  • Must have measurable disease, meaning the cancer can be detected and measured with tests such as blood work or imaging.
  • Must have an ECOG performance status score of 2 or lower. This scale measures how well you can carry out daily activities, where 0 = fully active and 2 = able to care for yourself but unable to work.

Who cannot join the trial?

19 criteria

  • Any serious medical condition or mental illness that would make it hard to understand the study information.
  • Use of any myeloma (blood‑cancer) medicine within 14 days before the first day of treatment.
  • Having had a stem cell transplant within the past 12 weeks, or having active graft‑versus‑host disease (GVHD) or taking medicines to suppress GVHD.
  • Receiving radiation therapy (except for pain‑relieving local treatment) for bone lesions caused by myeloma within 14 days before the first day of treatment.
  • Undergoing major surgery within 14 days before starting the study drug.
  • Known immediate or delayed allergic (hypersensitivity) reaction or unusual (idiosyncratic) reaction to mezigdomide, drugs similar to it, or any ingredients in the study medication.
  • Known immediate or delayed allergic reaction to other bispecific antibodies (lab‑made proteins that can bind two targets).
  • Any serious medical condition that would put the patient at an unacceptable risk in the study.
  • Having diseases that require long‑term steroid or immunosuppressive medicines, such as rheumatoid arthritis, multiple sclerosis, or lupus, which would likely need extra steroids or immune‑suppressing drugs during the study.
  • Being pregnant, breastfeeding, planning to become pregnant, or not using reliable birth control (such as double barrier methods, intrauterine device, or oral contraceptives) if able to become pregnant.
  • Being enrolled in another interventional clinical trial at the same time.
  • Having other plasma‑cell disorders like plasma cell leukemia, POEMS syndrome, or amyloidosis.
  • Previously treated with mezigdomide or any BCMA‑targeting bispecific antibody; prior BCMA‑targeted CAR T‑cell therapy or antibody‑drug conjugate (ADC) is allowed only if more than 6 months have passed since the last dose.
  • Having blood test results or other health measurements that do not meet the study’s required levels (non‑adequate hematological and/or non‑hematological parameters).
  • Having a left ventricular ejection fraction (LVEF) less than 50% (a measure of how well the heart pumps).
  • Having other serious diseases or health problems as defined in the study protocol.
  • Being infected with HIV, chronic or active hepatitis B, active hepatitis A, or active hepatitis C; if unsure, the virus must not be detectable in the blood.
  • Receiving live or live‑attenuated vaccines within 30 days before the first day of treatment.
  • Having had any other cancer (except certain skin cancers like basal cell carcinoma, skin epithelioma, or carcinoma in situ) within the past 5 years.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Elranatamab

    is a medicine given as a subcutaneous injection. It belongs to a group of treatments that help the immune system recognize and attack multiple myeloma cancer cells. In this study, elranatamab is being tested as a key part of the combination therapy to see if it can improve the body’s ability to control the disease.

  • Mezigdomide

    is an oral medication taken in capsule form. It works by targeting the cancer cells directly and can also help the immune system fight the myeloma. In the trial, mezigdomide is combined with elranatamab and another drug to see if the three together work better than each alone.

  • Dexamethasone

    is a steroid that is taken by mouth or injection. It helps reduce inflammation and can also make cancer cells more sensitive to other treatments. In this study, dexamethasone is used together with elranatamab and mezigdomide to support the overall effectiveness of the therapy.

What is already known about the treatment

Mezigdomide - Mezigdomide is taken as a small capsule that you swallow, delivering a dose of 0.3 to 0.6 mg orally. It is still an investigational drug being studied in clinical trials for blood cancers such as relapsed/refractory multiple myeloma. The medicine works by binding to a protein called cereblon, which changes the activity of other proteins and leads to the death of cancer cells. It is classified as a cereblon‑modulating immunomodulatory agent. Elranatamab - Elranatamab is given as a clear solution that is injected under the skin in a dose of 76 mg. It is also an investigational therapy currently in late‑stage trials for relapsed/refractory multiple myeloma. The drug is a bispecific antibody that attaches to a marker on myeloma cells (BCMA) and to T‑cells, directing the immune cells to kill the cancer cells. It belongs to the class of bispecific T‑cell engager antibodies.

Investigated diseases

Relapsed/refractory multiple myeloma - Relapsed/refractory multiple myeloma is a cancer of the plasma cells that reside in the bone marrow. It is marked by the production of abnormal antibodies and infiltration of marrow, which can cause anemia, fatigue, and bone pain. In the relapsed phase, the disease returns after an initial period of improvement, while refractory disease does not respond adequately to previous treatments. The condition typically progresses with increasing levels of abnormal plasma cells and worsening of blood and bone abnormalities. Over time, patients may develop more extensive marrow involvement and additional organ complications. Monitoring of disease markers helps to track its course.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526352-31-00Protocol codeGEM-MeziDELEstimated enrolment60 patientsSponsorFundacion PETHEMA

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.