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New dosing strategy for myeloma drug shows promise in early trial
NCT ID NCT05014412
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
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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
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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
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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 Hide 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
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Blood Cancer and Stem Cell Transplant Clinic
San Antonio, Texas, 78229, United States
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Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, 80528, United States
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China Medical University Hospital
Taichung, 40447, Taiwan
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Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
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East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
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East Jefferson General Hospital Bone Marrow Transplant Clinic
Metairie, Louisiana, 70006, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
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Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
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King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
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Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
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MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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MSK Bergen
Montvale, New Jersey, 07645, United States
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MSK Commack
Commack, New York, 11725, United States
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MSK Monmouth
Middletown, New Jersey, 07748, United States
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MSK Nassau
Uniondale, New York, 11553, United States
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MSK Westchester
Harrison, New York, 10604, United States
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Mayo Clinic
Scottsdale, Arizona, 85259, United States
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Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
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Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101, United States
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Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 78229, United States
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Methodist Hospital Investigational Pharmacy
San Antonio, Texas, 78229, United States
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Methodist Plaza Clinical Trials Office
San Antonio, Texas, 78229, United States
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Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
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National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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Poudre Valley Health System (PVHS)
Fort Collins, Colorado, 80528, United States
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Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
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St. David's South Austin Medical Center
Austin, Texas, 78704, United States
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Texas Oncology-South Austin
Austin, Texas, 78745, United States
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The Regents of the University of Michigan
Ann Arbor, Michigan, 48109, United States
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The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
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The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
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Tulane University
New Orleans, Louisiana, 70112, United States
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UCHealth Cancer Care & Hematology - Greeley
Greeley, Colorado, 80634, United States
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UCHealth Cancer Care & Hematology - Loveland
Loveland, Colorado, 80538, United States
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UF Health Shands Cancer Hospital
Gainesville, Florida, 32608, United States
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UF Health Shands Hospital
Gainesville, Florida, 32610, United States
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UF Health Shands Hospital Pharmacy Investigational Drug Service - Main
Gainesville, Florida, 32610, United States
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University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
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University College London Hospitals NHS Foundation Trust NIHR
London, W1T 7HA, United Kingdom
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University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?