New 5-Drug cocktail aims to tackle High-Risk myeloma
NCT ID NCT07600151
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new five-drug combination for people newly diagnosed with a high-risk form of multiple myeloma. The drugs include etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The trial will enroll 220 participants and first check safety, then see if the treatment can make cancer undetectable at a deep level. It is an early-stage study, so the results will show whether this approach is promising enough for larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone
- What this could lead to
- If successful, this could offer a more effective initial treatment for high-risk multiple myeloma, potentially leading to longer remission and survival.
- What could go wrong
- This is an early phase 1/2 trial, so safety and effectiveness are not yet proven. The five-drug combination may cause significant side effects, and results may not apply to 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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2036
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 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: * Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria. * Participants must have High-risk myeloma according to IMS/IMWG CGS * Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol. * Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions). * Participants must have clinical laboratory values within a prespecified range. Exclusion Criteria: * Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment. * known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia * Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol * known central nervous system involvement by MM.
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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
1 site. 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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University Medical Center Hamburg-Eppendorf
Hamburg, Germany
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