118 Participants Needed

Pomalidomide + Dexamethasone +/- Ixazomib for Multiple Myeloma

Recruiting at 335 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.

Who Is on the Research Team?

PV

Peter Voorhees, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not had any major surgery in the last 28 days.
I can take care of myself and am up and about more than half of my waking hours.
I have not been treated with, or my disease responds to, proteasome inhibitors.
See 23 more

Exclusion Criteria

I have never had AIDS or any serious HIV-related illnesses.
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2) must be met for patients opting to switch to the 3-drug regimen following disease progression

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Dose-escalation study of pomalidomide and ixazomib to establish the maximum tolerated dose

28 days
4 visits (in-person)

Phase II Treatment

Randomized study to assess progression-free survival with pomalidomide/dexamethasone/ixazomib versus pomalidomide/dexamethasone

3 years
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years
Every 4 weeks until disease progression, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Ixazomib
  • Pomalidomide
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (pomalidomide, dexamethasone, ixazomib)Experimental Treatment3 Interventions
Group II: Arm I (pomalidomide, dexamethasone)Experimental Treatment2 Interventions

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Celgene Corporation

Industry Sponsor

Trials
446
Recruited
58,500+
Mark Alles profile image

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer profile image

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Millennium Pharmaceuticals, Inc.

Industry Sponsor

Trials
406
Recruited
46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire profile image

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

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