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Proteasome Inhibitor

Ixazomib for Multiple Myeloma

Phase 2

Waitlist Available

Led By Shaji K. 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

Recovered (i.e., < grade 1 toxicity) from the reversible effects of prior antineoplastic therapy

Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens

Must not have

Known human immunodeficiency virus (HIV) positive

Arm E only: Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. (Note that FEV1 testing is required for subjects suspected of having chronic obstructive pulmonary disease and subjects must be excluded if FEV1 < 50% of predicted normal.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial study looks at the effects of ixazomib citrate on patients with multiple myeloma who have had a relapse, but are still responsive to bortezomib. Ixazomib citrate may prevent cancer cell growth by blocking some of the enzymes necessary for cell growth.

Who is the study for?

This trial is for patients with relapsed multiple myeloma who are not resistant to bortezomib. They should have recovered from previous treatments, have adequate organ function, and no severe concurrent illnesses. Those with certain infections or a recent history of other cancers (except nonmelanoma skin cancer) are excluded.

What is being tested?

The study tests ixazomib citrate's effectiveness in treating relapsed multiple myeloma when it's not refractory to bortezomib. It includes dexamethasone, cyclophosphamide, daratumumab, and lab biomarker analysis to see if the drug can halt cancer cell growth by blocking key enzymes.

What are the potential side effects?

Potential side effects may include fatigue, digestive issues like diarrhea or nausea, blood disorders such as low platelet counts or anemia, nerve damage that could cause pain or numbness (peripheral neuropathy), and increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from side effects of my previous cancer treatment.

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I have multiple myeloma and have undergone at least one standard treatment.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I am HIV positive.

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I have COPD with less than half the normal lung function.

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

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

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I have mild to no diarrhea without taking medication for it.

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I have recently undergone chemotherapy.

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I have not had major surgery 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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

Proportion of Confirmed Responses With Ixazomib Citrate Alone (Arm A [Closed]), Ixazomib Citrate With Dexamethasone (Arms B + C), or With Dexamethasone and Cyclophosphamide (Arm D), or With Dexamethasone, Cyclophosphamide, Daratumumab (Arm E)

Secondary study objectives

Confirmed Response Rate With the Addition of Dexamethasone (Arm A Only)

Event-free Survival

Incidence of Adverse Events

+1 more

Side effects data

From 2023 Phase 3 trial • 656 Patients • NCT02181413

39%

Nausea

35%

Diarrhoea

27%

Vomiting

25%

Upper respiratory tract infection

24%

Viral upper respiratory tract infection

22%

Arthralgia

22%

Cough

20%

Pyrexia

20%

Fatigue

19%

Back pain

11%

Headache

10%

Influenza

10%

Bronchitis

10%

Constipation

10%

Musculoskeletal pain

10%

Neuropathy peripheral

10%

Thrombocytopenia

Peripheral sensory neuropathy

Oedema peripheral

Herpes zoster

Muscle spasms

Bone pain

Influenza like illness

Asthenia

Pain in extremity

Dizziness

Insomnia

Conjunctivitis

Paraesthesia

Oropharyngeal pain

Productive cough

Anaemia

Pruritus

Rash maculo-papular

Pneumonia

Myalgia

Rash macular

Neutropenia

Pharyngitis

Sinusitis

Musculoskeletal chest pain

Hypertension

Decreased appetite

Dyspepsia

Metapneumovirus infection

Gastroenteritis

Lower respiratory tract infection

Myocardial ischaemia

Cellulitis

Osteonecrosis of jaw

Basal cell carcinoma

Plasma cell myeloma

Pathological fracture

Meniscus injury

Pleural effusion

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Ixazomib Citrate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm E (ixazomib citrate, cyclophosphamide, daratumumab)Experimental Treatment5 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm D (ixazomib citrate, dexamethasone, and cyclophosphamide)Experimental Treatment4 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm C (higher-dose ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions

Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm B (ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm A (ixazomib citrate and dexamethasone, closed to accrual)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. 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

Cyclophosphamide

2010

Completed Phase 4

~2310

Daratumumab

2014

Completed Phase 3

~2000