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Monoclonal Antibodies
Alnuctamab + Mezigdomide for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (up to approximately 5 years)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to find out the right amount and timing to give alnuctamab along with mezigdomide to patients with relapsed or refractory multiple myeloma. The study will
Who is the study for?
This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They should have tried at least three other treatments before joining Part A, and one to three prior treatments for Parts B and C. Those who've already taken alnuctamab or mezigdomide can't participate.
What is being tested?
The study is testing a combination of two drugs, Alnuctamab and Mezigdomide, along with Dexamethasone, in patients with relapsed/refractory multiple myeloma. It aims to find the best dose, schedule, safety profile, and early signs of effectiveness.
What are the potential side effects?
Possible side effects from Alnuctamab and Mezigdomide may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, and potential impacts on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (up to approximately 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (up to approximately 5 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
ORR
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Part AExperimental Treatment3 Interventions
Group II: Arm C2Experimental Treatment1 Intervention
Group III: Arm C1Experimental Treatment3 Interventions
Group IV: Arm B2Experimental Treatment3 Interventions
Group V: Arm B1Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mezigdomide
2023
Completed Phase 1
~40
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,028 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,650 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,445 Total Patients Enrolled
77 Trials studying Multiple Myeloma
28,963 Patients Enrolled for Multiple Myeloma