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Monoclonal Antibodies

Arm B1 for Multiple Myeloma

Phase 1 & 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of deaths

Number of participants with AEs leading to discontinuation

Number of participants with Dose-limiting toxicities (DLTs)

+3 more

Secondary outcome measures

Complete Response Rate (CRR)

Duration of Response (DOR)

ORR

+4 more

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

~2590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,698 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,707 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,508 Previous Clinical Trials

3,370,267 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,131 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who are being enrolled in this clinical investigation?

"Indeed, clinicaltrials.gov information highlights that this trial is actively enrolling subjects. The trial was initially posted on February 27th, 2024 and last updated on March 13th, 2024. Enrolment aims to reach a total of 156 participants spread across three designated sites."

Answered by AI

Is the enrollment for this investigation presently open?

"As per the information available on clinicaltrials.gov, this investigation is actively seeking participants. It was initially shared online on February 27th, 2024 and most recently revised on March 13th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

2024. "A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163898.