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Monoclonal Antibodies
Arm A: Alnuctamab for Multiple Myeloma (ALUMMINATE Trial)
Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles)
Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy
Must not have
Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention
Active, uncontrolled, or suspected infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is aiming to determine if alnuctamab is effective and safe for treating people with relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for people with multiple myeloma that has come back or hasn't responded to treatment. Participants should have already tried some therapies and meet specific health standards, but the exact criteria aren't listed here.
What is being tested?
The study tests alnuctamab against standard treatments for relapsed or refractory multiple myeloma. These include drugs like Carfilzomib, Elotuzumab, Daratumumab, Pomalidomide, and Dexamethasone.
What are the potential side effects?
While not specified here, common side effects of these drugs can include fatigue, nausea, risk of infection due to low blood cell counts, nerve damage symptoms like numbness or tingling in hands and feet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with lenalidomide and an anti-CD38 drug for at least 2 cycles.
Select...
I have seen improvement in my myeloma after treatment.
Select...
I have had 1 to 3 treatments for myeloma.
Select...
I am willing and able to follow the study's schedule, including hospital stays and bone marrow tests.
Select...
I have been diagnosed with multiple myeloma.
Select...
My last treatment for myeloma did not work or my condition worsened.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stem cell transplant from a donor or my own cells within the last 3 months.
Select...
I do not have an active, uncontrolled infection.
Select...
My multiple myeloma has affected or previously affected my brain or spinal cord.
Select...
I have a significant brain or spinal cord condition.
Select...
I have received BCMA-targeted therapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: AlnuctamabExperimental Treatment1 Intervention
Group II: Arm B: Standard of Care RegimensActive Control5 Interventions
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Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,440 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,806 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,568 Previous Clinical Trials
3,384,364 Total Patients Enrolled
76 Trials studying Multiple Myeloma
29,104 Patients Enrolled for Multiple Myeloma
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