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Monoclonal Antibodies

Daratumumab + Ixazomib + Dexamethasone for Amyloidosis

Phase 1

Waitlist Available

Led By Hans C Lee

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Male patients agreeing to specific contraceptive measures

Diagnosis of primary systemic AL amyloidosis confirmed by Congo red staining of tissue showing apple green birefringence and clonal plasma cell disorder demonstrated by immunohistochemistry, in situ hybridization, or flow cytometry on bone marrow biopsy, or monoclonal protein on serum or urine electrophoresis/immunofixation

Must not have

Non-AL amyloidosis

Severe obstructive airway disease defined by forced expiratory volume at one second (FEV1) < 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

Approved for 60 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating patients with amyloid light chain amyloidosis.

Who is the study for?

This trial is for adults with AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have an acceptable level of organ function and performance status, not be pregnant or breastfeeding, and agree to use contraception. Those with severe infections, recent major surgeries or treatments, certain other cancers within the last 2 years, or specific heart diseases cannot join.

What is being tested?

The study tests the combination of daratumumab (a monoclonal antibody), ixazomib (chemotherapy), and dexamethasone (a steroid) to treat AL amyloidosis. It aims to find the safest doses and see how well they work together against this disease by stopping tumor cells from growing.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to daratumumab, chemotherapy-related issues like nausea and hair loss from ixazomib, as well as possible increased infection risk and blood sugar changes due to dexamethasone.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use contraception as required.

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I have been diagnosed with AL amyloidosis confirmed by specific tests.

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My platelet count is at least 75,000 without recent transfusions.

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My kidneys are functioning well enough to clear waste.

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I am able to care for 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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My condition is not light-chain (AL) amyloidosis.

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My lung function is severely reduced, with less than half the normal airflow.

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I haven't had radiotherapy in the last 2 weeks, or last week if it was a small area.

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I haven't taken strong CYP3A inducers, Ginkgo biloba, or St. John's wort in the last 14 days.

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I have a GI condition that may affect medication absorption.

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I have severe nerve pain or numbness in my hands or feet.

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I do not have serious heart problems.

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I have not had major surgery in the last 2 weeks.

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I have been treated with daratumumab or ixazomib, or was in a study with ixazomib.

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My condition is diagnosed as active myeloma.

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I do not have an active infection, hepatitis B or C, or HIV.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity rate

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, ixazomib, dexamethasone)Experimental Treatment3 Interventions

Participants receive daratumumab IV over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

FDA approved

Ixazomib

FDA approved

Dexamethasone

FDA approved

0 / 17Eligibility criteria met