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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

118 Participants Needed

Trial Summary

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.

Research Team

Peter Voorhees, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Arm II (pomalidomide, dexamethasone, ixazomib) Experimental Treatment 3 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 Treatment 2 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.

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

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

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

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

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

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand