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Monoclonal Antibodies

Belantamab Mafodotin + Pomalidomide + Dexamethasone for Multiple Myeloma

Atlanta, GA

Phase 2

Recruiting

Led By Ajay K. Nooka, MD,MPH,FACP

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.03) must be =< grade 1 at the time of enrolment except for alopecia

Participant must be >= 18 years of age

Must not have

Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment

Participant must not have an active infection requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat patients with high-risk myeloma. The drugs work in different ways to kill cancer cells or stop their growth.

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Who is the study for?

This trial is for adults over 18 with high-risk myeloma who've had a stem cell transplant within the last year and are not pregnant or breastfeeding. They should have certain genetic markers, good organ function, no severe eye disease, infections, or allergies to study drugs. Participants must agree to use contraception.Check my eligibility

What is being tested?

The trial tests belantamab mafodotin (a targeted antibody-chemotherapy combo), pomalidomide (a chemotherapy drug), and dexamethasone (an anti-inflammatory) in treating high-risk myeloma patients to see if this combination kills more cancer cells.See study design

What are the potential side effects?

Potential side effects include vision problems due to corneal changes, liver issues like jaundice or cirrhosis, kidney problems requiring dialysis, nerve damage causing neuropathy, bleeding risks from blood disorders and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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All my side effects from previous cancer treatments are mild, except for hair loss.

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I am 18 years old or older.

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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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My blood test shows 20% or more plasma cells.

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My cancer is high-risk due to specific genetic changes.

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I have had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.

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Exclusion Criteria

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

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I am not allergic to belantamab mafodotin or similar drugs.

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I do not have any infections that need treatment.

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I do not have any known heart risks.

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I do not have any serious eye surface diseases.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I am not allergic to the study drugs or similar compounds.

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I am at high risk and did not reach partial remission after my stem cell transplant.

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I cannot take certain blood thinners due to allergies or side effects.

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I have a known brain or spinal cord condition.

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I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that didn't spread.

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I do not have any current bleeding from my internal organs or mucous membranes.

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I do not have severe liver problems like cirrhosis or jaundice.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Minimal residual disease (MRD) negativity rate

+5 more

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: Treatment (belantamab mafodotin, pomalidomide, dexamethasone)Experimental Treatment3 Interventions

Patients receive belantamab mafodotin IV over 30 minutes on day 1 of every other cycle, pomalidomide PO QD on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Pomalidomide

2011

Completed Phase 2

~1060