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Monoclonal Antibodies

Radiation Therapy + Talquetamab for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Scott R Goldsmith

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of multiple myeloma with extramedullary disease (EMD). EMD is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions (i.e., the EMD is not contiguous with any bone/bony lesion)

Target EMD site must be encompassed by one radiation field per treating radiation oncologist

Must not have

Prior GPRC5D therapy

Prior irradiation to target EMD site or field

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment for multiple myeloma patients with extramedullary disease, where cancer cells spread to organs and tissues. They will use external beam radiation therapy (EBRT)

Who is the study for?

This trial is for multiple myeloma patients with extramedullary disease, where cancer cells have spread to organs and tissues. Participants must meet specific health criteria not detailed here.

What is being tested?

The trial tests a combination of external beam radiation therapy (EBRT) directed at cancer sites and talquetamab, a monoclonal antibody that may inhibit cancer growth, in treating multiple myeloma with extramedullary disease.

What are the potential side effects?

Potential side effects include typical reactions to radiation like skin changes or fatigue, and those related to talquetamab such as immune system reactions or infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I have multiple myeloma with cancer spread outside the bone marrow.

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My cancer can be targeted in one radiation field.

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I have been treated with drugs that boost the immune system, target proteins in cancer cells, and an anti-CD38.

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My kidneys are functioning well enough, as shown by tests.

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I am 18 years old or older.

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I can care for myself but may need occasional assistance.

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My tests show measurable signs of my disease.

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I have recovered from side effects of cancer treatment, except for hair loss.

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I completed my last cancer treatment at least 2-4 weeks ago, depending on the type.

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I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

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

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I have previously received GPRC5D therapy.

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I have had radiation therapy on the cancer area I want to target.

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I have a heart condition.

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I have an active hepatitis B or C infection.

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My multiple myeloma has spread to my brain or spinal cord.

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I have been diagnosed with a specific blood disorder.

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I am not pregnant or breastfeeding.

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I have had radiopharmaceutical therapy before.

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I have had radiation on more than a quarter of my bone marrow.

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I have had a stem cell transplant from a donor within the last 6 months or from myself in the last 12 weeks.

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I have taken less than 140 mg of prednisone or its equivalent in the last 14 days.

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I haven't had major surgery in the last 2 weeks and won't need any during the study.

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I currently have an infection.

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I have severe asthma or COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Extramedullary disease (EMD)-modified overall response rate (ORR) (phase 2)

Incidence of adverse events (phase 1b)

Secondary study objectives

Clinical benefit rate

Duration of response

Incidence of adverse events

+2 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 (EDM-EBRT, talquetamab)Experimental Treatment9 Interventions

STEP-UP PERIOD: Patients undergo EMD-EBRT QD for 5 treatment fractions on weekdays (Monday to Friday), and receive talquetamab SC starting after the first fraction of EMD-EBRT and continuing every 2-4 days for up to 3 step-up doses in the absence of unacceptable toxicity. SUBSEQUENT TREATMENT: Starting 2-7 days after step-up dose 3, patients receive talquetamab SC on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to a maximum of 13 total cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT and collection of blood samples throughout the trial and undergo image-guided EMD biopsy at screening and on study. Patients undergo bone marrow biopsy/aspiration at screening and optionally at end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Biospecimen Collection

2004

Completed Phase 3

~2030