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A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509472-42-00
Acronym
CA058-1019
Enrollment
177
Registered
2024-04-16
Start date
Unknown
Completion date
2024-05-17
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed and/or Refractory Multiple Myeloma

Brief summary

The main thing the researchers are looking at is called "progression-free survival" (“PFS”). This means the time from when a person starts the treatment to when their cancer gets worse, or they die from any cause

Detailed description

They will also look at how long people live overall, which is called “overall survival” ("OS")., The researchers will also look at other things to see how well the treatment works. These include how well the cancer responds to the treatment, how long the cancer responds, and how long it takes for people to start a new treatment., They will also look at any side effects people have while taking the treatment and how it affects their quality of life., Overall, the researchers want to see if alnuctamab is a safe and effective treatment for people with multiple myeloma.

Interventions

DRUGDARZALEX 1800 mg solution for injection
DRUGImnovid 2 mg hard capsules
DRUGImnovid 3 mg hard capsules
DRUGImnovid 1 mg hard capsules
DRUGKyprolis 60 mg powder for solution for infusion
DRUGDEXAMETHASONE
DRUGImnovid 4 mg hard capsules

Sponsors

Celgene International II S.a.r.l.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The main thing the researchers are looking at is called "progression-free survival" (“PFS”). This means the time from when a person starts the treatment to when their cancer gets worse, or they die from any cause

Secondary

MeasureTime frame
They will also look at how long people live overall, which is called “overall survival” ("OS")., The researchers will also look at other things to see how well the treatment works. These include how well the cancer responds to the treatment, how long the cancer responds, and how long it takes for people to start a new treatment., They will also look at any side effects people have while taking the treatment and how it affects their quality of life., Overall, the researchers want to see if alnuctamab is a safe and effective treatment for people with multiple myeloma.

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026