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Corticosteroid

Triple Drug Regimen for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Shaji Kumar, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Diagnosis of multiple myeloma (MM) with deletion 17p (del17p) or monosomy 17 by fluorescence in situ hybridization (FISH) who have received at least one line of therapy

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

Must not have

Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period

Known human immunodeficiency virus (HIV) positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing idasanutlin, ixazomib citrate, and dexamethasone to see if they're effective in treating patients with multiple myeloma that has returned.

Who is the study for?

This trial is for patients with relapsed multiple myeloma, specifically those who have certain genetic changes (deletion 17p or monosomy 17). Participants must have had at least one prior therapy, adequate organ function, and agree to use birth control. Excluded are those with significant neuropathy, recent major surgery, other active cancers needing treatment, known allergies to study drugs, heart conditions within the last six months, uncontrolled infections or diseases that could affect participation.

What is being tested?

The trial is testing a combination of idasanutlin and ixazomib citrate with dexamethasone in patients whose multiple myeloma has returned. It aims to find the best dose while assessing how these drugs might stop cancer growth by killing cells or preventing them from dividing and spreading.

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as fatigue, nausea, risk of infection due to low blood counts; nerve damage symptoms like numbness or pain; possible liver issues indicated by elevated enzymes; gastrointestinal problems including difficulty swallowing; and increased risk of bleeding.

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 a specific genetic change and have undergone treatment.

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

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My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.

Exclusion Criteria

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

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I have moderate to severe nerve damage in my hands or feet, or mild with pain.

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I am HIV positive.

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I am not pregnant or breastfeeding.

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I have mild or no diarrhea and am not on antidiarrheal medication.

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I have been treated with ixazomib or was in a study for it.

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I do not have uncontrolled heart conditions or recent heart attacks.

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I need medication to prevent blood clots.

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I haven't taken strong CYP3A4 medications in the last 14 days.

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I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.

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I have not had major surgery in the last 14 days.

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

Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)

The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)

Secondary study objectives

Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)

Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)

Overall Survival (Phase II)

+3 more

Other study objectives

Changes in Macrophage Inhibitory Cytokine-1 (MIC) Levels

Impact of MDM2 Inhibition on Activation of p53 and Clonal Selection

Potential Biomarkers Associated With Response Determined Using Gene Expression Profiling

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 (ixazomib citrate, idasanutlin, dexamethasone)Experimental Treatment5 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and idasanutlin PO QD on days 1-5 every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 every 28 days for 12 courses at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Idasanutlin

2020

Completed Phase 2

~450