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New drug shows promise for Hard-to-Treat multiple myeloma

NCT ID NCT04649359

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing a drug called elranatamab in 187 people with multiple myeloma whose cancer has not responded to at least three other types of treatment. The drug works by helping the body's immune cells attack the cancer cells. The main goal is to see how many patients have their cancer shrink or disappear.

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 drug that helps the immune system attack cancer cells)
What this could lead to
If successful, this could provide a new treatment option for people with multiple myeloma who have run out of other options.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The drug may cause side effects or not work for all patients.

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

187 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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 * Cohort A: has not received prior BCMA-directed therapy * Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells) * ECOG performance status ≤2 * 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 * Amyloidosis * POEMS syndrome * Stem cell transplant within 12 weeks prior to enrollment * 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. * 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)

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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

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204, United States

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342, United States

  • CHU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • CHU de Poitiers, Pôle Régional de Cancérologie

    Poitiers, 86021, France

  • CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

    Pierre-Bénite, 69495, France

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612, United States

  • Clinica Universitaria de Navarra

    Madrid, 28027, Spain

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Epworth Healthcare

    Richmond, Victoria, 3121, Australia

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511, Japan

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Loyola University Chicago performing research at Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Regional Cancer Care Associates, LLC

    Hackensack, New Jersey, 07601, United States

  • St Francis Physician Services Inc

    Greenville, South Carolina, 29601, United States

  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria, 3065, Australia

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

    Poznan, 60-569, Poland

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • The Alfred

    Melbourne, Victoria, 3004, Australia

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UCLA Hematology/Oncology Clinic

    Los Angeles, California, 90095, United States

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg, 20246, Germany

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10021, United States

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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