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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

+9 more

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

dexamethasone

1995

Completed Phase 3

~9860

ixazomib

2014

Completed Phase 1

~30

pomalidomide

2011

Completed Phase 3

~1060

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,520 Total Patients Enrolled

18 Trials studying Multiple Myeloma

15,375 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,035 Total Patients Enrolled

578 Trials studying Multiple Myeloma

188,612 Patients Enrolled for Multiple Myeloma

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,118 Total Patients Enrolled

73 Trials studying Multiple Myeloma

10,431 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02004275 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Arm II (pomalidomide, dexamethasone, ixazomib), Arm I (pomalidomide, dexamethasone)

Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02004275 — Phase 1 & 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02004275 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do other trials exist which demonstrate the use of pomalidomide?

"Initially tested in 2002, pomalidomide has been subject to 1153 studies. At present, there are 591 active experiments conducted at the Greenville site in North carolina and other locations."

Answered by AI

Is there an active search underway to identify participants in this experiment?

"This medical trial has ended its recruitment period. It was first posted on February 1st, 2014 and then revised for the last time on January 10th 2022. For those who are still searching for trials to join, 807 clinical studies related to multiple myeloma have opened sign-ups while 591 other trials make use of pomalidomide treatments with open enrollment periods."

Answered by AI

What medical issues does pomalidomide commonly address?

"Pomalidomide is often used to treat ophthalmic diseases like sympathetic eye and branch retinal vein occlusion. It can additionally be employed in the management of macular edema."

Answered by AI

How many venues are currently hosting this investigation?

"This trial is administered by East Carolina University in Greenville, North carolina, Lakeland Hospital Niles in Niles, Illinois and NorthShore University HealthSystem-Evanston Hospital in Evanston, Ohio. Additionally there are 100 other sites participating."

Answered by AI

What is the participant count for this research endeavor?

"At present, this research is not taking on any new candidates. It was initially posted in February 2014 and the last edit occurred 10th January 2022. Should you be exploring other studies related to multiple myeloma, 807 trials are currently recruiting; if pomalidomide interests you then 591 clinical studies are actively seeking patients."

Answered by AI

Recent research and studies

American Journal of HematologyJournal

A Phase I/ <scp>ii</scp> Study of Ixazomib, Pomalidomide, and Dexamethasone for Lenalidomide and Proteasome Inhibitor Refractory Multiple Myeloma (alliance <scp>a061202</scp> )

Voorhees, Peter M., Vera J. Suman, Sascha A. Tuchman, Jacob P. Laubach, Hani Hassoun, Yvonne A. Efebera, Flora Mulkey, et al.. 2021. “A Phase I/ ii Study of Ixazomib, Pomalidomide, and Dexamethasone for Lenalidomide and Proteasome Inhibitor Refractory Multiple Myeloma (alliance a061202 )”. American Journal of Hematology. Wiley. doi:10.1002/ajh.26361.

clinicaltrials.govStudy

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma

2014. "Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02004275.

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