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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

ALUMMINATE 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.Check my eligibility

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.See study design

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.

ALUMMINATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with lenalidomide and an anti-CD38 drug for at least 2 cycles.

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I have seen improvement in my myeloma after treatment.

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I have had 1 to 3 treatments for myeloma.

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I am willing and able to follow the study's schedule, including hospital stays and bone marrow tests.

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I have been diagnosed with multiple myeloma.

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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.

ALUMMINATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Progression-free Survival (PFS)

Secondary outcome measures

Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)

Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)

Complete response (CR) or better

+12 more

ALUMMINATE 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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,505 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,397 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,064 Total Patients Enrolled

72 Trials studying Multiple Myeloma

24,821 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.

Are potential participants currently able to apply for enrollment in this research study?

"As per clinicaltrials.gov, this specific clinical trial is not actively recruiting participants at the moment. The trial was initially posted on March 13th, 2024 and last updated on January 22nd, 2024. However, it's worth noting that there are currently 801 other ongoing clinical trials welcoming potential candidates for participation."

Answered by AI

Are there numerous facilities conducting this clinical trial within the borders of the United States?

"A total of 281 clinical trial sites are actively running this study. Examples include Banner MD Anderson Cancer Center located in Gilbert, Arizona Clinical Research Center situated in Tucson, and the University of Alabama at Birmingham found in Birmingham. Additionally, there are 281 other locations participating as well."

Answered by AI

Has the United States Food and Drug Administration granted approval for Alnuctamab in Arm A?

"Arm A, which involves the administration of Alnuctamab, is classified as a Phase 3 trial. The safety rating for this arm is assessed at 3 due to existing evidence supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

2024. "A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232707.