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Monoclonal Antibodies

Isatuximab + Belantamab for Multiple Myeloma (ISABELA Trial)

Phase 2

Waitlist Available

Led By Andrew Yee, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

All study participants must be registered into the mandatory Pomalyst REMS program and be willing and able to comply with the requirements of the Pomalyst REMS program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time from start of treatment to disease progression or death from any cause, for up to 10 years. patients who have not progressed or died are censored at the date last known progression-free.

Awards & highlights

ISABELA Trial Summary

This trial evaluates treating relapsed/refractory multiple myeloma with isatuximab and belantamab mafodotin.

Who is the study for?

Adults with relapsed/refractory multiple myeloma who have adequate liver function, can take aspirin daily, and are not pregnant or breastfeeding. Participants must agree to contraception methods and join the Pomalyst REMS program. They should be able to swallow capsules whole, have an ECOG status ≤ 2, certain levels of hemoglobin and measurable disease indicators.Check my eligibility

What is being tested?

The trial is testing a combination of drugs: Isatuximab, Belantamab Mafodotin (Bela Maf), Pomalidomide (Pom), and Dexamethasone (Dex) for their effectiveness in treating multiple myeloma that has come back or hasn't responded to treatment.See study design

What are the potential side effects?

Possible side effects include eye issues (especially if wearing contact lenses), increased risk of infections due to low blood cell counts, potential liver problems indicated by hepatic function requirements, fatigue from dexamethasone use, as well as other organ inflammation.

ISABELA Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am registered and can follow the Pomalyst REMS program requirements.

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My multiple myeloma shows through specific blood or urine tests.

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I can take daily aspirin for blood thinning.

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I agree to follow pregnancy tests and use effective birth control during and for 4 months after the study.

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I can swallow capsules without breaking or crushing them.

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I can take care of myself and am up and about more than half of my waking hours.

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I have had treatment for my multiple myeloma that came back or didn't respond to treatment.

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My kidney function, measured by creatinine clearance, is adequate.

ISABELA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time from start of treatment to disease progression or death from any cause, for up to 10 years. patients who have not progressed or died are censored at the date last known progression-free.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time from start of treatment to disease progression or death from any cause, for up to 10 years. patients who have not progressed or died are censored at the date last known progression-free.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from start of treatment to disease progression or death from any cause, for up to 10 years. patients who have not progressed or died are censored at the date last known progression-free. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Number of Adverse Events

Overall survival (OS)

Progression Free Survival (PFS)

ISABELA Trial Design

1Treatment groups

Experimental Treatment

Group I: Isatuximab + Belantamab mafodotin + Pomalidomide + DexamethasoneExperimental Treatment4 Interventions

Isatuximab will be given once daily into your vein (by intravenous infusion) over about 30-60 minutes. This will occur during cycle 1 (cycle equals 28 days) on days 1, 8, 15, and 22 and cycle 2 and onwards days 1 and 15. Belantamab mafodotin will be given once every 8 weeks into your vein (by intravenous infusion) over about 60 minutes after completion of isatuximab infusion. Pomalidomide will be taken orally once daily during days 1-21 of each cycle. Dexamethasone will be taken orally once daily during days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Drug diaries will be provided to participants to document information about taking pomalidomide and dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Isatuximab

2016

Completed Phase 3

~370

Belantamab mafodotin

2019

Completed Phase 1

~10

Pomalidomide

2011

Completed Phase 2

~1020

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,305 Total Patients Enrolled

35 Trials studying Multiple Myeloma

2,618 Patients Enrolled for Multiple Myeloma

SanofiIndustry Sponsor

2,163 Previous Clinical Trials

3,512,430 Total Patients Enrolled

47 Trials studying Multiple Myeloma

10,151 Patients Enrolled for Multiple Myeloma

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,422 Total Patients Enrolled

47 Trials studying Multiple Myeloma

6,383 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05922501 — Phase 2

Multiple Myeloma Research Study Groups: Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone

Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT05922501 — Phase 2

Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05922501 — Phase 2

Frequently Asked Questions

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

Is participation in this research project available to individuals at present?

"Clinicialtrials.gov's records demonstrate that this trial is no longer accepting recruits, with its initial posting dated back to November 30th 2023 and last edited on June 19th 2023. Despite the lack of recruitment for this particular study, 826 other clinical trials are actively searching for participants."

Answered by AI

Are there any adverse effects associated with Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone?

"Our experts at Power assign a score of 2 to Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone's safety due to the presence of limited evidence confirming its safety in Phase 2 trials but not yet any data suggesting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Andrew Yee, MD 2024. "Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05922501.