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Corticosteroid

Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Paul Richardson, MD

Eligibility Criteria Checklist

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

Must have

Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment

Patients with relapsed and relapsed refractory myeloma

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat multiple myeloma in patients who have not responded to other treatments.

Who is the study for?

This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have tried at least two therapies, be in decent physical shape (able to perform daily activities), and not have had certain other treatments recently. Women who can get pregnant must follow specific pregnancy testing rules.

What is being tested?

The study tests a combination of three drugs: Ixazomib, Pomalidomide, and Dexamethasone given twice weekly for patients whose Multiple Myeloma has relapsed or is refractory. It's designed to see how safe this mix is and how well it works.

What are the potential side effects?

Possible side effects include digestive issues, blood clots, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, allergic reactions, and others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma and need treatment now.

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My myeloma has returned after treatment.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

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

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I have a GI condition or had surgery that may affect medication absorption.

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I am not pregnant or breastfeeding.

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I have heart problems that are not well-managed.

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I take more than the specified amount of corticosteroids daily.

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I am not currently infected with HIV, HBV, or HCV.

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I have been diagnosed with POEMS syndrome.

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I have amyloidosis or plasma cell leukemia with symptoms.

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I cannot tolerate blood clot prevention treatments.

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I have been treated with ixazomib or my condition did not improve with pomalidomide.

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My nerve damage symptoms are mild or moderate without pain.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with dose limiting toxicity

Overall Response Rate

Secondary study objectives

Duration of Response

Overall Survival

Progression Free Survival

+1 more

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: ixazomib plus pomalidomide and dexamethasoneExperimental Treatment3 Interventions

The study drugs will be administered within a 21-day cycle * Phase I will follow a standard "3 +3" dose escalation design: Starting with the first cohort, 3 to 6 patients will be treated at this and each subsequent dose level. * The Phase II portion of the study will be a single-arm open-label enrollment with dosing based on the MTD determination in the Phase I portion of the study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3510

Pomalidomide

2011

Completed Phase 2

~1060