Can a Four-Drug combo tame Ultra-High-Risk myeloma?
NCT ID NCT07789522
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding elranatamab to a standard three-drug regimen can improve outcomes for people newly diagnosed with ultra-high-risk multiple myeloma. Researchers will give 15 participants elranatamab, isatuximab, bortezomib, and lenalidomide, and measure how many achieve minimal residual disease negativity, meaning no cancer cells are detectable. The study also tracks side effects, response rates, and how long any remission lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- elranatamab (an anti-BCMA/CD3 bispecific antibody) given as a subcutaneous injection, combined with isatuximab, bortezomib, and lenalidomide
- What this could lead to
- If it works, this combination could offer a more effective first-line treatment for ultra-high-risk multiple myeloma, potentially improving remission rates and delaying relapse.
- What could go wrong
- This is a small, early-phase study with only 15 participants, so results may not apply broadly. The drug combination may cause side effects, and the trial does not guarantee a cure or long-term benefit.
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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- 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: 1. The subject voluntarily signs the informed consent form (ICF). 2. Aged 18-70 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria: 1. Serum M-protein ≥1.0 g/dL 2. Urine M-protein ≥200 mg/24 hours 3. Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria: (1)del(17p) with a clonal fraction \>20% and/or a TP53 mutation (2)An IGH translocation \[t(4;14), t(14;16), or t(14;20)\] combined with 1q+ or del(1p32) (3)del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion (5)β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level Exclusion Criteria: 1. Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis. 2. Peripheral neuropathy of Grade \>1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization. 3. Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients. 4. Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment. 5. Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.
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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 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.
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