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Ixazomib Maintenance for AL Amyloidosis

Phase 2

Waitlist Available

Led By Heather Landau, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Measurable disease as defined by serum differential free light chain concentration (dFLC) ≥ 50 mg/L (or M-protein of 0.5g/dl) prior to initial therapy

At least one organ involved with AL amyloidosis including renal, cardiac, GI/Liver, peripheral/autonomic nervous system and/or soft tissue disease

Must not have

Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib

Female patients who are lactating or have a positive serum pregnancy test during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Ixazomib maintenance treatment can help control AL Amyloidosis and prevent or delay relapse.

Who is the study for?

This trial is for adults with AL Amyloidosis who've had a partial response to initial therapy, have organ involvement, and are within 12 months of starting treatment. They must not have severe neuropathy or active infections, be pregnant or breastfeeding, or have other recent cancers. Men and women must follow specific contraception guidelines.

What is being tested?

The study tests if Ixazomib can control AL Amyloidosis after initial therapy success. It's given as maintenance chemotherapy to prevent disease relapse. Patients will also receive Dexamethasone as part of the treatment regimen.

What are the potential side effects?

Ixazomib may cause side effects like gastrointestinal issues (nausea, vomiting), low blood counts leading to increased infection risk or bleeding problems, skin rash, fatigue, and potential nerve damage (neuropathy).

Eligibility Criteria

Inclusion Criteria

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

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My blood tests show significant markers for my disease.

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My AL amyloidosis affects at least one organ, like my kidneys, heart, or liver.

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I have completed at least 2 cycles of initial treatment or had a stem cell transplant.

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

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My blood cancer responded partially to my first treatment.

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My diagnosis of AL amyloidosis is confirmed by a biopsy.

Exclusion Criteria

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

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I have a stomach or intestine condition that could affect how I absorb pills.

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I am not pregnant or breastfeeding.

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My condition did not improve with proteasome inhibitor treatments.

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I do not have any active infections, including hepatitis B or C.

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I have severe nerve pain in my hands or feet that isn't controlled by medicine.

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My multiple myeloma is causing damage to my organs.

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I have heart problems that are not well-managed.

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I haven't taken strong medication or St. John's wort in the last 14 days.

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My condition is primary refractory AL amyloidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

event free survival (EFS)

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

29%

Diarrhoea

24%

White blood cell count decreased

20%

Platelet count decreased

16%

Rash

16%

Neutrophil count decreased

11%

Pneumonia

Constipation

Malaise

Pyrexia

Anaemia

Nasopharyngitis

Decreased appetite

Taste disorder

Acute kidney injury

Influenza

Bile duct stone

Gastroenteritis

Pneumonia bacterial

Bone pain

Febrile neutropenia

Duodenal ulcer

Enterocolitis

Tibia fracture

Interstitial lung disease

Prinzmetal angina

Compression fracture

Spinal compression fracture

Tumour lysis syndrome

100%

80%

60%

40%

20%

Study treatment Arm

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

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: ixazomibExperimental Treatment2 Interventions

Enrolled patients will receive ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle. Ixazomib will be given orally on days 1, 8, and 15 of a 28 day cycle. Dexamethasone 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue. Treatment cycles will be repeated until disease progression for up to 24 cycles or until development of significant treatment-related toxicities.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Ixazomib

2017

Completed Phase 4

~3510