Carfilzomib + Pomalidomide + Dexamethasone + Daratumumab for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Andrzej Jakubowiak, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Eligibility Criteria

This trial is for adults over 18 with relapsed or refractory multiple myeloma who've had at least one prior treatment and are not planning a stem cell transplant soon. They must have measurable disease, be able to follow the study plan, use birth control, and have good liver function and blood counts. People can't join if they've had recent cancer treatments, heart issues, certain other cancers within 3 years, uncontrolled conditions like hypertension or diabetes, active infections requiring drugs, HIV/AIDS, significant neuropathy or allergies to related drugs.

Inclusion Criteria

I am 18 years old or older.

Must agree to practice abstinence or use two acceptable methods of birth control

Written informed consent

Exclusion Criteria

Pregnant or lactating

You have had an allergic reaction to mannitol, thalidomide, lenalidomide, or pomalidomide in the past.

I have been diagnosed with POEMS syndrome.

Participant Groups

The study tests adding carfilzomib to pomalidomide and dexamethasone in patients with multiple myeloma that has come back or didn't respond to treatment. It also looks at the effects of including daratumumab in this combination therapy. The trial involves increasing doses of these drugs to find out how well they work together.

Group I: PdC Group Experimental Treatment 3 Interventions

Patients receive carfilzomib, pomalidomide, and dexamethasone at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.

Group II: PdC + Dara Group Experimental Treatment 4 Interventions

Patients receive carfilzomib, pomalidomide, dexamethasone, and daratumumab at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Kyprolis for:

• Multiple myeloma

🇪🇺 Approved in European Union as Kyprolis for:

• Multiple myeloma

🇨🇦 Approved in Canada as Kyprolis for:

• Multiple myeloma

🇯🇵 Approved in Japan as Kyprolis for:

• Multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Health Network - Princess Margaret Cancer Center Toronto, Canada

Sarah Cannon Research Institute Nashville, TN

University of Michigan Comprehensive Cancer Center Ann Arbor, MI

University of Chicago Comprehensive Cancer Center Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

Multiple Myeloma Research Foundation Collaborator

National Cancer Institute (NCI) Collaborator

References