New drug combo aims to tackle Hard-to-Treat myeloma
NCT ID NCT05927571
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 7 times
Summary
This early-stage trial is testing whether combining two drugs, cevostamab and elranatamab, is safe and tolerable for people with multiple myeloma that has returned or not responded to prior treatments. About 120 participants will receive the drugs, and researchers will monitor side effects and determine the best dose for future studies. The goal is to find a new option for this difficult-to-treat blood cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cevostamab and elranatamab (two cancer drugs given by infusion or injection)
- What this could lead to
- If this combination works, it could offer a new treatment option for people with multiple myeloma that has come back or stopped responding to other therapies.
- What could go wrong
- This is an early Phase 1 trial, so the main goal is safety, not proof of effectiveness. The drugs may cause side effects like cytokine release syndrome, and the combination might not work better than existing treatments.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Diagnosis of R/R MM per IMWG criteria * For female participants of childbearing potential: agreement to remain abstinent or use contraception * For male participants: agreement to remain abstinent or use a condom Exclusion Criteria: * Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5) * Prior treatment with elranatamab * Prior allogeneic stem cell transplantation (SCT) * Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells * Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome * Participants with known history of amyloidosis * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * Peripheral motor polyneuropathy of prespecified grade * Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Human immunodeficiency virus (HIV) seropositivity * History of central nervous system (CNS) myeloma disease * Significant cardiovascular disease
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Get notified about this study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center.
RECRUITINGSeoul, 05505, South Korea
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Calvary Mater Newcastle
RECRUITINGWaratah, New South Wales, 2298, Australia
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Hadassah University Hospital - Ein Kerem
RECRUITINGJerusalem, 9112001, Israel
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Rambam Health Care Campus
RECRUITINGHaifa, 3109600, Israel
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Royal Adelaide Hospital;Haematology Clinical Trials Unit
RECRUITINGAdelaide, South Australia, 5000, Australia
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Samsung Medical Center - PPDS
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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St. Vincent's Hospital Melbourne
RECRUITINGMelbourne, Victoria, 3065, Australia
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Tel Aviv Sourasky Medical Center PPDS
RECRUITINGTel Aviv, 6423906, Israel
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The Alfred Hospital
RECRUITINGPrahan, Victoria, 3181, Australia
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The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
RECRUITINGSeocho, 06591, South Korea
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The Chaim Sheba Medical Center - PPDS
RECRUITINGRamat Gan, Central District, 5262100, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding selinexor to standard therapy extend remission in Hard-to-Treat myeloma?
- Can a new drug combo outsmart Hard-to-Treat myeloma?
- Engineered immune cells take on Hard-to-Treat myeloma
- Home infusion for myeloma drug passes early safety check
- New hope for multiple myeloma: phase 3 trial launches
- New CAR T-Cell therapy targets Hard-to-Treat myeloma