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New shot aims to wipe out myeloma in patients out of options

NCT ID NCT06282978

Disease control Sponsor: PETHEMA Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a drug called elranatamab in 50 people with multiple myeloma that has relapsed or stopped responding after at least one prior treatment. Participants have already tried three main drug classes. The goal is to see if elranatamab can reduce the cancer to undetectable levels in the bone marrow. The drug is given as a weekly shot, and if it works well, the dosing may be reduced to every other week.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elranatamab (a targeted antibody drug given as a shot under the skin)
What this could lead to
If successful, this could offer a new treatment option for patients with multiple myeloma that has stopped responding to other therapies, potentially achieving very deep remissions.
What could go wrong
This is an early-phase (Phase 2) study with only 50 participants, so results may not apply to all patients. The drug can cause serious side effects like cytokine release syndrome, nerve toxicity, and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, 18 years or older (at the time consent is obtained). * Patient who, in the investigator's opinion, is able to comply with the protocol requirements. * Prior diagnosis of MM as defined according to IMWG criteria. * Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. * Relapse multiple myeloma patients that have received at least 1 or 2 prior lines of therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be also have been exposed to pomalidomide) and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab). * Patients must be refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment. * Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients in whom disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio. Exclusion Criteria: * Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma-cells proliferative disorder, and skin changes) or plasma cell leukemia. * Prior anti-BCMA treatment. * Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. * History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy. * Stem cell transplant within 12 weeks prior to enrolment.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma in relapse

Contacts and locations

Locations

  • C.H. de Toledo (Virgen de la Salud)

    Toledo, 45005, Spain

  • CHU de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Complejo Asistencial Universitario de León

    León, Spain

  • H. Clínic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario Salamanca

    Salamanca, 37007, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Clínico Universitario de Santiago ~ CHUS

    Santiago de Compostela, A Coruña, 15706, Spain

  • Hospital Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital de Cabueñes

    Gijón, 33394, Spain

  • Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

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