Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byPaul Richardson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Paul Richardson, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.

Eligibility Criteria

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.

Inclusion Criteria

I've had at least two treatments for my condition or one if it included specific drugs and my disease got worse within 60 days after treatment.

Registered into the mandatory POMALYST REMS® program and willing and able to comply with its requirements

I agree to follow the pregnancy testing schedule as required.

+7 more

Exclusion Criteria

I do not have any health or personal issues that would make it hard for me to follow the study's requirements.

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

I am not pregnant or breastfeeding.

+19 more

Participant Groups

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.

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

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

🇪🇺 Approved in European Union as Dexamethasone for: