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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

Must not have

Autologous stem cell transplant <6 months prior to start of treatment

Allogeneic stem cell transplant <12 months prior to initiation of study treatment

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

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant using my own cells less than 6 months ago.

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I had a stem cell transplant from a donor less than a year ago.

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Side effects from my past cancer treatment have mostly gone away.

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I had cancer other than multiple myeloma but have been free of it for over 3 years.

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I have significant nerve pain or tingling that hasn't improved with treatment.

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I have not received a live vaccine in the last 30 days.

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I do not have any serious eye surface (corneal) diseases.

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I have previously received anti-BCMA therapy.

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My condition did not improve after initial treatment.

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I am currently taking high doses of corticosteroids.

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

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

Number of Adverse Events

Overall survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Pomalidomide

2011

Completed Phase 2

~1060

Dexamethasone

2007

Completed Phase 4

~2650