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Proteasome Inhibitor

Quadruple Therapy for Multiple Myeloma

Phase 1 & 2

Recruiting

Led By Prashant Kapoor

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Age >= 18 years at the time of signing the informed consent form (ICF)

Must not have

Known to be human immunodeficiency virus (HIV) positive, known or suspected active hepatitis C infection, or seropositive for hepatitis B

Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for newly diagnosed multiple myeloma, to see if it is more effective than current treatments and has fewer side effects.

Who is the study for?

Adults with newly diagnosed multiple myeloma who haven't been treated or have had only one treatment cycle. They must have measurable disease, be in good physical condition, and have proper organ function. Pregnant or breastfeeding individuals can't join, nor can those unwilling to use contraception or those with certain medical conditions that could interfere with the trial.

What is being tested?

The IDEAL study is testing a combination of drugs: Iberdomide (an immunotherapy), Daratumumab (a monoclonal antibody), Bortezomib (blocks enzymes for cell growth), and Dexamethasone (chemotherapy). The goal is to find the best dose of Iberdomide and see how well these drugs work together against multiple myeloma.

What are the potential side effects?

Possible side effects include immune system changes leading to inflammation in various organs, infusion reactions from antibodies, fatigue from chemotherapy, potential blood disorders due to enzyme inhibition by Bortezomib, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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I have measurable cancer lesions outside of my bone marrow.

Exclusion Criteria

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

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I am HIV positive or have active hepatitis B or C.

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I have a blood disorder but it's not active cancer.

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I do not have any uncontrolled illnesses that could affect my trial participation.

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I have undergone more than one treatment cycle for my multiple myeloma.

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I am not pregnant, not nursing, and willing to use contraception if of childbearing potential.

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 (Phase II)

Maximum tolerated dose (MTD) of iberdomide (Phase I)

Secondary study objectives

Incidence of adverse events (AEs) (Phase II)

Overall response rate (Phase II)

Overall survival (Phase II)

+3 more

Other study objectives

Minimal residual disease

Proportion of patients who achieve sustained MRD negative status

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

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 (iberdomide, bortezomib, dexamethasone, daratumumab)Experimental Treatment4 Interventions

INDUCTION PHASE: Patients receive iberdomide PO QD on days 1-21, bortezomib SC on days, 1, 8, 15, and 22, and dexamethasone PO on days 1, 8, 15, 22. Patients also receive daratumumab SC on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 13-36 CYCLES: Patients receive iberdomide PO QD on days 1-21. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-220

Not yet FDA approved

Bortezomib

FDA approved

Daratumumab

FDA approved

Dexamethasone

FDA approved