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Corticosteroid

Pomalidomide + Dexamethasone +/- Ixazomib for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Proteasome inhibitor naive or sensitive disease

No primary refractory multiple myeloma

Must not have

No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of two drugs, pomalidomide and ixazomib, when given together with dexamethasone, to treat patients with multiple myeloma that has come back.

Who is the study for?

This trial is for patients with relapsed multiple myeloma who have previously been treated and are lenalidomide-refractory. They should not have had major surgery, chemotherapy, or radiation within specific time frames before joining the trial. Participants must practice safe contraception if applicable, have no active hepatitis B/C or hypersensitivity to study drugs, meet certain blood count criteria, and cannot be HIV positive with certain conditions.

What is being tested?

The study is testing how well a combination of pomalidomide and dexamethasone works with or without ixazomib in treating relapsed multiple myeloma. It aims to determine the best dose and side effects of these drugs together while assessing their effectiveness in stimulating the immune system to stop cancer growth.

What are the potential side effects?

Possible side effects include immune system reactions that may affect organ function, increased risk of infections due to bone marrow suppression leading to low blood cell counts, potential heart issues from drug interactions affecting cardiac function, fatigue from anemia caused by reduced red cells production, as well as digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I have not been treated with, or my disease responds to, proteasome inhibitors.

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My multiple myeloma did not resist initial treatment.

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I am a man who will either not have sex or will use a condom with women who can get pregnant.

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I do not have AL amyloidosis or POEMS syndrome.

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My cancer has not spread to my brain or spinal cord.

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I have never had a severe skin reaction from thalidomide or lenalidomide.

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I have not had any major surgery in the last 28 days.

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I can take care of myself and am up and about more than half of my waking hours.

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I do not have plasma cell leukemia.

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My cancer can be measured by tests or seen on scans.

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My condition worsened despite first-line treatment with lenalidomide.

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I have had one treatment for my multiple myeloma.

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I am not taking medication that strongly affects certain liver enzymes.

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I have never been treated with Pomalidomide.

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My multiple myeloma has returned after previous treatment.

Exclusion Criteria

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

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I have never had AIDS or any serious HIV-related illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Maximum Tolerated Dose (MTD) of Pomalidomide and Ixazomib, Determined According to Incidence of Dose Limiting Toxicity (DLT) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Phase I)

Progression Free Survival (PFS) (Phase II)

Secondary study objectives

Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II)

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (pomalidomide, dexamethasone, ixazomib)Experimental Treatment3 Interventions

Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (pomalidomide, dexamethasone)Experimental Treatment2 Interventions

Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pomalidomide

2011

Completed Phase 3

~1110

ixazomib

2014

Completed Phase 1

~30