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New dosing strategy for myeloma drug shows promise in early trial

NCT ID NCT05014412

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new way of giving the drug elranatamab to people with multiple myeloma that came back or didn't respond to treatment. The drug was given as a shot under the skin, starting with low doses and then increasing, with longer breaks between doses over time. The goal was to see if this approach is safe and works well. 86 people took part in the study.

What this could mean

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

Active substance
Elranatamab
What this could lead to
If successful, this could provide a new treatment option for patients with multiple myeloma that has returned or not responded to prior therapies.
What could go wrong
This is an early-phase study with only 86 participants, so results may not apply to all patients. Side effects like cytokine release syndrome are a known risk.

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

86 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014) * Measurable disease, as defined by at least 1 of the following: 1. Serum M-protein \>0.5 g/dL by SPEP 2. Urinary M-protein excretion \>200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio * Refractory to at least one IMiD * Refractory to at least one PI * Refractory to at least one anti-CD38 antibody * Relapsed/refractory to last anti-myeloma regimen * ECOG performance status ≤1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 * Not pregnant and willing to use contraception Exclusion Criteria: * Smoldering multiple myeloma * Active Plasma cell leukemia * POEMS syndrome * Amyloidosis * Waldenström's macroglobulinemia * Known active CNS involvement or clinical signs of myelomatous meningeal involvement * Stem cell transplant within 12 weeks prior to enrollment or active GVHD * Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 malignancy with minimal risk of recurrence per investigator. * Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy. * Live attenuated vaccine within 4 weeks of the first dose * Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer) * Known or suspected hypersensitivity to the study intervention, or any of its excipients

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Blood Cancer and Stem Cell Transplant Clinic

    San Antonio, Texas, 78229, United States

  • Cancer Care & Hematology - Fort Collins

    Fort Collins, Colorado, 80528, United States

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195, United States

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006, United States

  • East Jefferson General Hospital Bone Marrow Transplant Clinic

    Metairie, Louisiana, 70006, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935, Japan

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen

    Montvale, New Jersey, 07645, United States

  • MSK Commack

    Commack, New York, 11725, United States

  • MSK Monmouth

    Middletown, New Jersey, 07748, United States

  • MSK Nassau

    Uniondale, New York, 11553, United States

  • MSK Westchester

    Harrison, New York, 10604, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101, United States

  • Methodist Healthcare System of San Antonio dba Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Methodist Hospital Investigational Pharmacy

    San Antonio, Texas, 78229, United States

  • Methodist Plaza Clinical Trials Office

    San Antonio, Texas, 78229, United States

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Poudre Valley Health System (PVHS)

    Fort Collins, Colorado, 80528, United States

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Oncology-South Austin

    Austin, Texas, 78745, United States

  • The Regents of the University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT, United Kingdom

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • UCHealth Cancer Care & Hematology - Greeley

    Greeley, Colorado, 80634, United States

  • UCHealth Cancer Care & Hematology - Loveland

    Loveland, Colorado, 80538, United States

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

  • UF Health Shands Hospital Pharmacy Investigational Drug Service - Main

    Gainesville, Florida, 32610, United States

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University College London Hospitals NHS Foundation Trust NIHR

    London, W1T 7HA, United Kingdom

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH, United Kingdom

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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Other studies related to the condition(s) this trial covers.